IAJPR

Indo American Journal of Pharmaceutical Research

ISSN NO.: 2231-6876
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NOVEMBER 2017
1

METABOLITE ANALYSIS OF HUGONIA MYSTAX L. (LINACEAE) LEAVES FROM SOUTH-WEST REGION OF INDIA

Sandip Pawar1, Atul Lavand1, Anilkumar Vaidya2, Debjani Dasgupta3*

1The Institute of Science, 15 Madam Cama Road, Mumbai – 400032, India.

2GES Ayurved Medical College, Ranicalvesh, Kolhapur – 416012, Maharashtra, India.

3School of Biotechnology and Bioinformatics, D. Y. Patil University, Sector – 15, Plot No. 50, C.B.D. Belapur, Navi Mumbai – 400614, India.

Hugonia mystax Linn., is an ethanobotanically important plant which plays a vital role in primary healthcare of tribals from Tiruvannamalai hills, Tamil Nadu, India. There is paucity in the literature regarding the active phytoconstituents of H. mystax contributing to the biological activities claimed by traditional healers. Therefore, the present investigation aims to analyze the metabolite profile of leaf extracts of H. mystax. Quantitative determination of total phenolic and flavonoid of leaves was carried out. The highest amount of phenolic and flavonoid was found in ethanol extracts of the leaves. RP-HPLC analysis of individual phenolic compounds revealed the presence of Gallic acid, Catechol, Caffeic acid, Vanillin, p-Coumaric acid and Ferulic acid. Catechol was found to be the highest in water extract. GC-MS of chloroform fraction and LC-MS of methanol/water fraction led to the identification of 19 and 21 compounds respectively. Chloroform fraction revealed the presence of 1-Hexanol (37.69%), Cinnamene (13.81%) and p-Xylol (9.39%), whereas, methanol/water fraction revealed the presence of p-Myrcene (19.5%), 4-Vinyphenol (12.72%) and p-Vinylguaiacol (4-VG) (7.82%) respectively as the major compounds. This is the very first report of metabolite analysis of leaves of H. mystax L. from south-west region of India. This investigation identified the major phytoconstituents predominantly present in leaves, which may probably be responsible for the traditional claims of its therapeutic properties.

2

PHARMACOGNOSTIC INVESTIGATION OF PLANT OF BREYNIA RETUSA (DENNST). (FAMILY - EUPHORBIACEAE)

Y. Bhagyasri, N. Siva Subramanian, R. Karthikeyan

Gland Institute of Pharmaceutical sciences, Sy No.551, Shangri-La, Kothapet (V), Sivampet (M), Near Narsapur, Medak (Dist) Telangana, 502313.

Pharmacognostic standardization including physico-chemical evaluation is meant for identification, authentication, and detection of adulteration and also compilation of quality control standards of crude drugs. Standardization of herbal drugs has traditionally been based on appearance and today microscopic evaluation is indispensable in the initial identification of herbs, as well as in identifying small fragments of crude or powdered herbs and detection of foreign matter and adulterants. Therefore the present study is to investigate the macroscopical, microscopical, and physico-chemical characteristics of the plant of Breynia Retusa (Dennst). (Family - Euphorbiaceae). The results obtained from the study may play a major role in setting particular standards for the plant of Breynia Retusa (Dennst). This might broaden its pharmacognostic, pharmacological, botanical and economical importance.

3

EFFECT OF FORMULATION EXCIPIENTS ON AEROSOLISATION PERFORMANCE OF BUDESONIDE

Alpana Kulkarni,Vijaya Jagnade*, Kanchan Hole

MAEER’S Maharashtra Institute of Pharmacy, S. No. 124, MIT Campus, Paud Road, Kothrud, Pune-411038, Maharashtra, India.

The marketed dry powder inhalations (DPI) are based on lactose monohydrate alone and lactose anhydrous is neither studied nor used as a carrier in marketed DPIs. Lactose is not recommended as a carrier in budesonide formulations since lactose interacts with amine functional group. This study was carried out to investigate the effect of lactose anhydrous inhalation grade 40 M on the aerosolisation performance of budesonide. The work was also aimed at study of an interaction between budesonide and the lactose carriers in dry state. The powder properties of binary formulations, consisting of lactose anhydrous LA 40M and budesonide, were compared with those of lactose monohydrate LM 40 M and budesonide. In vitro drug release was determined with diffusion cell. Based on the results of the preliminary study, two promising formulations F1 and F2 were subjected to the in vitro deposition study using Twin Stage Impinger and Lupihaler®. The results revealed absence of chemical reaction between budesonide and both the grades of lactose namely, LM and LA. Hence lactose can be used as a carrier in budesonide dry powder formulations. The aerosolisation performance of DPIs, consisting of either lactose monohydrate 40M or lactose anhydrous 40M, was similar. The particle size distribution, particle density, morphology, surface roughness, flowability and moisture content of lactose carriers played a complex role in determining fine respirable fraction of budesonide. The in vitro deposition profile of budesonide was improved significantly when budesonide was blended with LM 40M or LA 40M in 1:45 ratio.

4

“SYNTHESIS AND ANTI-BACTERIAL ACTIVITY OF SOME NOVEL PYRAZOLIDINEDIONE SUBSTITUTED DERIVATIVES OF 2-QUINOLONES”

Syed Hafeez Ahmed1, Haney Ahmed2, Syed Habeeb Ali2, Sabiha Fatima2, Shafia Hyder2, Amjad Pasha2

1Department of Pharmaceutical Analysis and Quality Assurance, Shadan College of Pharmacy, Peeran Cheru, Hyderabad.

2Department of Chemistry, Shadan College of Pharmacy, Peeran Cheru, Hyderabad.

Although a number of drugs are available in the market, thrust for discovery of new antimicrobial drugs with better pharmacokinetic profile, and lesser toxicity has become necessary in the field of medicinal chemistry due to fast development of microbial resistance towards the existing molecules. The 2(1H) quinolinone, often referred to as carbostyril moiety, is an important structural unit present in many biologically active molecules. Quinolone antibiotics have gained wide acceptance for the treatment of various bacterial infections. Their mode of action is believed to involve inhibition of bacterial DNA gyrase, an enzyme essential for DNA replication. Many natural and synthetic products containing heterocyclic rings such as pyrazoles, pyrazolones, and isoxazolidines and pyrazolidinediones were reported to possess varied pharmacological activities. Research on 2-quinolone and pyrazolidine 3,5-dione and their synthetic analogs have revealed to possess various pharmacological activities along with wide range of antimicrobial activity. It is our interest to synthesize some new 2-quinolones containing pyrazolidinedione moiety and evaluate their antimicrobial activity.

5

PHYTOCHEMICAL EXTRACTION OF STEM OF SIDA ACUTA BURM. F.

Mushraf Qureshi, Mukta Shrivastava

Department of Botany, Govt. M. L.B. Girls P.G. (Autonomous) College, Bhopal; 462002. M.P. India.

Plants and plant based products are bases of many modern pharmaceuticals that are currently in use today for various diseases. Sida acuta Burm. f. belonging to Malvaceae is a perennial shrub found growing, well in many soils. The plant is frequently found in pastures, cultivated lands and along the roadsides. It has a variety of traditional uses. The decoction of the entire plant is taken orally for curing asthma, fever, aches and pains, ulcers and also several other diseases. Sida acuta is known to have analgesic, anti-inflammatory, hypoglycemic and hepatoprotective activity. The present study was undertaken to analyse the various phytochemical constituents in the stem of Sida acuta. The phytochemical investigation revealed the presence of various phytoconstituents such as Alkaloids, Phenols, tannis, Proteins and amino acids. However, it also contains small amount of Carbohydrates and glycosides.

6

METHOD DEVELOPMENT AND VALIDATION OF HYDRALAZINE HYDROCHLORIDE BY USING UV AND RP-HPLC

Ms. M. Monika1,2*, B. Swathi1, Md. Faheemuddin2

1School of Pharmacy (Formerly Lalitha College of Pharmacy), Anurag Group of Institutions, Venkatapur, Ghatkesar, Ranga Reddy Dist. -501 301, INDIA.

2Smt. Sarojini Ramulamma College of Pharmacy, Seshadrinagar, Mahabubnagar-509001.

A simple, rapid, precise and highly selective spectrophotometric method was developed for estimation of Hydralazine Hydrochloride in tablet dosage form. This method, involves the measurement of absorbances of Hydralazine at the wavelength of 262nm. Distilled water was used as solvent. Linearity was observed in the concentration range of 2-20?g/ml. The accuracy of the method was found to be 99.2%. The LOD and LOQ of Hydralazine was found to be 0.051?g/ml and 0.16?g/ml. The method showed good reproducibility and recovery with % RSD less than 2. A selective, precise, isocratic and accurate reverse phase high performance liquid chromatographic method was developed for the determination of Hydralazine Hydrochloride in the tablet dosage form. A chromatographic separation was achieved on reverse phase BDS Hypersil C18 column (250 ×4.6 mm, 5?). The mobile phase consists of mixture of Methanol and Acetonitrile. The flow rate was 1.2ml/min and the effluents were monitored at the wavelength of 270nm.The retention time of Hydralazine HCl was found to be 2.58min respectively. Hydralazine HCl was found to be linear in the range of 0.5 to 4 ?g/ml with the recoveries of 98 % and 100.5 %.The method was validated as per ICH guidelines. In proposed methods good results were obtained and can be applied for the routine analysis of formulation.

7

DETERMINATION OF BIO PHARMACEUTICAL COMPONENTS OF A NOVEL POLY HERBAL FORMULATION BY GC – MS ANALYSIS.

S. Selvakumar*, J. Sindhuja

Department of Industrial BioTechnology, Bharath University, Chennai-600073, India

The present study aims to investigate and characterize the chemical composition of the chloroform extract of a novel poly herbal formulation was studied. The air dried plant materials were powdered and further subjected to gas chromatography and mass spectrometry. Qualitative determination of the different Pharmacologically and biologically active compounds from chloroform extract of a novel poly herbal formulation using gas chromatography and mass spectrometry revealed different types of high and low molecular weight chemical entities with varying quantities present in the extract. These chemical compounds are considered biologically and pharmacologically important. Furthermore, the chloroform extract of a novel poly herbal formulation possess unique physicochemical characteristics which may be attributed to the compounds naturally present in significant quantities in the herbal formulation. The chloroform extract of a novel poly herbal formulation possess 13 major bioactive compounds that were identified and characterized spectroscopically. Hence, identification of different bio pharmacologically active compounds may warrants further biological and pharmacological studies.

8

CHARACTERIZATION AND EVALUATION OF ANTIOXIDANT ACTIVITY OF OCIMUM CANUM LEAVES AND ITS EFFECIENCY ON SCHISTOSOMA MANSONI LARVAL STAGE

Heba Abdel-Hady, Mahfouz Mohamed Abdel-Gawad and Eman Ahmed El-Wakil

Medicinal Chemistry Laboratory, Theodor Bilharz Research Institute, Warrak El-Hader, Giza, Egypt.

Schistosomiasis is the most endemic disease caused by the genus Schistosoma. Its control is dependent on killing the worm itself or one of its larval stages. The objective of this study is to determine the total phenolic and flavonoid contents, evaluating the antioxidant activity of Ocimum canum leaf methanol extract by DPPH and ABTS as well as investigating the efficiency of plant extract against Schistosoma mansoni larval stages. Also, GC-MS analysis of plant extract was carried out. The results revealed that Ocimum canum leaf methanol extract showed high total phenolic content (321.78±0.69 mg GAE/g extract) and flavonoid content (71.64±10.66 mg RE/g extract). Furthermore, there is a significant correlation between the concentration of the extract and the inhibition percentage of the free radicals. The higher inhibition percentage of plant extract was recorded by DPPH than ABTS at 500?g/ml (84% and 62%) respectively. Also, IC50 of DPPH and ABTS (26.41±1.39 and 194.45±2.03) respectively. Regarding to ceracricidal and miracidicidal activity, the plant extract showed larvicidal activity as it killed 82% of cercariae while, it was completely lethal to miracidia at 500ppm within 2 hours. On the other hand, 36 chemical compounds were identified from plant extract. The main components are Phytol (23%), Hexadecanoic acid, methyl ester (15.48%), 9,12,15-Octadecatrienoic acid methyl ester (14.99%), n-Hexadecanoic acid (7.62%), 9,12,15-Octadecatrienoic acid (5.04%), Ethyl linoleate (3.58%) and 2-Propenoic acid, 3-phenyl-, methyl ester (3.17%). This study suggested that Ocimum canum can be used as promising plant to control schistosomiasis disease as well as its potential antioxidant activity.

9

A VALIDATED SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND LEVOCETIRIZINE DIHYDROCHLORIDE IN TABLET FORMULATIONS

Mr. G. K. Dyade

SVPM’s College of Pharmacy,Malegaon(BKII), Tal. Baramati Dist. Pune 413115

A simple, precise and accurate spectrophotometric method was developed for simultaneous estimation of Ambroxol HCl and LevoCetirizine DiHCl in bulk and tablet dosage form. This method is based on use of Derivative method for simultaneous estimation of both the drug from tablet and Distilled water is used as solvent. Ambroxol HCl shows maximum absorption at 244nm and LevoCetirizine DiHCl shows absorption at 231 nm. Ambroxol HCL and LevoCetirizine HCl obeys Beer,s law in the concentration range 0-32 ug/ml and 0-30ug/ml respectively.During estimation of Tablet no interference was found from excipients. The dosage form contains 60 mg Ambroxol HCl and 5 mg LevoCetirizine DiHCl.The suitability of this method for estimation of both drugs was proved by validation. Statistical analysis data shows that the developed method is sound under analytical condition and can be used for routine analysis of both drugs.

10

“FORMULATION AND EVALUATION OF COLON TARGETED pH DEPENDENT MICROCAPSULES OF Nigella sativa L. EXTRACT FOR COLORECTAL CANCER”

Afsana Nazeer*, Neema George

Department of Pharmaceutics, Department of Pharmaceutical sciences, Centre for Professional and Advanced Studies, Rubber board P.O, Kottyam-686009, Kerala.

The aim of the present work was to prepare the colon-targeting pH dependent microcapsules of Nigella sativa extract for the treatment of colorectal cancer. In this study, colon targeted microcapsules of Nigella sativa extract was formulated successfully using pH dependent polymers Eudragit L100, S100 using solvent evaporation method (method 1 and method 2). Microcapsules were evaluated for flow properties, surface morphology by scanning electron microscopy, percentage yield, drug content, and in vitro drug release behaviour and in vivo targeting efficiency. The good flowability and packability of microcapsules, indicates that they can be successfully handled and either filled into a capsule or compressed into tablet dosage form. The scanning electron microscopy of the microcapsules (5 ?m) revealed that they are spherical. N. sativa extract loaded microcapsules demonstrated good entrapment efficiency (of 83.159% in method 1 and 93.09% in method 2). The drug release study revealed that the microcapsules were capable to retard the drug release of drug up to 4 hours and efficiently released in colon (85.69%). Formulation done by method 2 gave most promising result compared to first method. So, the in vivo colon targeting efficiency of the formulation was done with microcapsules prepared by method 2. Determination of the in vivo targeting efficiency concluded that the formulation is able to target colonic region effectively. It is concluded from the present study that pH dependent Eudragit microcapsules are promising carriers for oral colon-targeted delivery of N. sativa extract for colorectal cancer.

11

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ETELCALCETIDE IN BULK AND ITS DOSAGE FORM USING RP-HPLC

Shabana Sultana1*, Dr R. Vani 2, Dr M. Sunitha3

1Department of Pharmaceutical Analysis and Quality Assurance, Shadan Women’s College of Pharmacy, Hyderabad.

2Department of Pharmaceutical Analysis, Shadan Women’s College of Pharmacy, Hyderabad.

3Shadan Women’s College of Pharmacy, Hyderabad.

A simple and precise RP-HPLC method was developed for the estimation of the Etecalcetide. Initially, various mobile phase compositions were tried to separate title ingredients. Mobile phase and flow rate selection was based on peak parameters (height, tailing, theoretical plates capacity or symmetry factor) run time and resolution. Finally The mobile phase containing mixture of 50% OPA buffer 50% methanol with the flow rate of 1.0 ml/ min. The optimum wavelength for detection was 235nm at which better detector response for drug was obtained. The Retention time for Etelcalcetide was found to be 4.653min respectively. To ascertain its effectiveness, system suitability test were carried out on fresh prepared stock solutions. The regression 0.999 respectively. The low value of % R.S.D indicate the method is precise and accurate.

12

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND TENELIGLIPTIN IN BULK AND ITS DOSAGE FORM USING RP-HPLC

Kaneez Fatima*, Dr. R. Vani, Dr. M. Sunitha

Department of Pharmaceutical Analysis and Quality Assurance, Shadan Women’s College Pharmacy, Hyderabad,India.

A new method was developed for simultaneous estimation of Teneligliptin and Metformin by RP-HPLC. The chromatographic conditions were successfully carried out on Inertsil ODS column C8 (4.6x250mm) of 5?m particle size, flow rate was 1.0ml/min, using mobile phase composed of 50% buffer: 50% Acetonitrile, detection wavelength used as 240 nm. The instruments and materials used were WATERS, software: Empower, 2695 separation module.2487 UV detector, UV/VIS spectrophotometer-LABINDIA UV 3000+. The retention time was found to be for Metformin 3.608 min and for Teneligliptin 5.148 min. The assay of Metformin and Teneligliptin was performed with tablets and the % assay was found to be 99.97 and 100.64 which shows that the method is useful for routine analysis. The linearity of Metformin and Teneligliptin was found to be linear with a correlation coefficient of 0.999 and 0.999, which shows that the method is capable of producing good sensitivity.The acceptance criteria of precision is RSD should be not more than 2.0% and the method show precision 0.4 and 0.8 for Metformin and Teneligliptin which shows that the method is precise.The acceptance criteria of intermediate precision is RSD should be not more than 2.0% and the method show precision 0.1 and 0.7 for Metformin and Teneligliptin which shows that the method is repeatable when performed in different days also. The accuracy limit is the percentage recovery should be in the range of 97.0% - 103.0%. The total recovery was found to be 99.86% and 99.96% for Metformin and Teneligliptin. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The acceptance criteria for LOD and LOQ is 3 and 10. The LOD and LOQ for Metformin was found to be 3.00 and 9.98 and LOD and LOQ for Teneligliptin was found to be 3.02 and 10.00. The linearity of Teneligliptin and Metformin was found to be linear with a correlation coefficient of (R2) 0.998 and 0.999 respectively. The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions. The analytical method was validated according to ICH Guidelines.

13

INCREASED RISK OF ENDOMETRIAL CARCINOMA AND ACCURACY IN THE DIAGNOSIS OF PATIENTS: A GYNECOLOGIC STUDY

Matta Jyothi Sravani, Guvvala Gayathri, A. Deevan Paul*

SVU College of Pharmaceutical Sciences, SV University, Tirupati- 517502.

In sharp difference to numerous other tumor sorts, the occurrence and mortality of endometrial disease keep on growing. This awful pattern is, in no little section, an aftereffect of the overall corpulence pandemic. The greater part of endometrial tumor as of now owing to heftiness, which is perceived as an autonomous hazard factor for this sickness. In this survey, we recognize the sub-atomic systems by which heftiness and fat tissue add to the pathogenesis of endometrial growth. We additionally talk about the effect of stoutness on the clinical administration of the malady and look at the improvement of normal behavioural and pharmaceutical intercessions went for diminishing endometrial tumor chance, enhancing malignancy results, and saving fruitfulness in an inexorably more youthful populace of patients with endometrial growth.

14

FORMULATION OF ANTIMALASSEZIC SHAMPOO FROM DATURA METEL AND PROSOPIS JULIFLORA

R. S. A. Sorna Kumar*, R. Amara Bharathi, R. Lakshmipriya, C. Suganya Devi, A. Sivaranjani, T. Banumathi,

Department of Biotechnology, Jeppiaar Engineering College, Chennai-600119, Tamil Nadu.

Department of Biotechnology, P.S.R Engineering College, Sivakasi-626140, Tamil Nadu

Prosopis belongs to the family Leguminosae, is a native of Americas, Africa and Asia, Prosopis species grows fast, are drought-resistant, nitrogen fixing shrubs. Extracts of Prosopis juliflora seeds and leaves have several in vitro pharmacological effects such as antibacterial, antifungal, anti-inflammatory properties. Datura metel L., is a perennial herbaceous plant, belonging to the Solanaceae family. In Ayurvedic medicine, seeds of D. metel are used to treat Skin rashes, Ulcers, Bronchitis, Jaundice and Diabetes. The present study was to evaluate the antidandruff activity of datura metel and p.juliflora and thereby developing a shampoo using the simple standard protocol. The shampoo formulated was studied for their pH using a digital pH meter and the pH of 6.82, 7.24, 6.93 and 7.42 was obtained for the extracts of leaves and seed of P. Juliflora and D.metel respectively. We found that both the extracts possessed excellent antioxidant, antibacterial and antimalassezic activity. The formulated shampoo too was found to be effect. Incorporating the extracts of Datura metal and P.juliflora into shampoo as an antidandruff agent will be useful in treating people affected with excess dandruff. Further studies are also needed to enhance the properties of the prepared shampoo.

15

PLIGHTS AND PREDICAMENTS IN THE PHARMACY INDUSTRY

Neha Naaz1*, Khaja Uzair ul Hasan1, Aaminah Najmus Sahar1, Prof. Dr. Osman Ahmed2

1Deccan School of Pharmacy, Nampally, Hyderabad, India – 500001.

2Hyderabad, India-500001.

We provide an insight to the troubles in the field of pharmacy. Using the published literature to date, we review the impact of various challenges in the field of Pharmacy. The pharmaceutical industry has succumbed to the challenges presented by the consumer, other healthcare fields, policies, emergence of telemedicine, sunken research inputs, low drug approval, diminished new drug release in the market, demolishing new drug acceptance and utility. These factors have provided considerable damage to the pharmaceutical industry which can be explicated by the languishing market growth. The consumer aimed advertising meant for profit has the patients educated about branded drugs and also has mislead them to drug abuse. The misled and educated patients have deteriorated the market of generic drugs. The conflict in the marketing of NMEs, Biologics and Biosimilars creates yet another hurdle. The growth of approval of new drugs compared to the year 2016 was just 3% this year. The non-revising policies do not tend to improve the profit of the drug manufacturers but favour the economy of the consumer alone. The industry is spiralling and requires stabilization. We conclude by suggestions by newer reformed policies, better innovations, clear sources of information, thorough pharmacovigilance and well counselled consumers.

16

ASSESSMENT OF IN VITRO ANTIOXIDANT AND ANTIHAEMOLYTIC ACTIVITIES IN TRITICUM AESTIVUM GRASS AND CARICA PAPAYA LEAVES

Sonia Johri*, Neha Khan

ITM University, AH-43, Jhansi Road, Gwalior, Madhya Pradesh 475001.

The study deals with the comparative evaluation of various extracts of Triticum aestivum (Wheat) grass and Carica papaya (Papaya) leaves by phytochemical screening followed by antioxidant and antihaemolytic activities as revealed by various parameters such as reducing power, nitric oxide (NO) scavenging activity, diphenyl picrylhydrazine (DPPH) free radical scavenging activity, superoxide dismutase assay, H2O2 and hypotonic solution induced haemolysis assay. The phytochemical screening showed high flavonoids, phenolic and alkaloids content which indicates antioxidant strength of the extract. In wheatgrass and papaya leaves n-butanol and aqueous extracts have high scavenging activities compared to ethyl acetate and petroleum ether extracts. All the four extracts (petroleum ether, ethyl acetate, n-butanol, aqueous) scavenge free radicals to a certain extent but n-butanol and aqueous extract exhibited more potential effect among all four extracts. Thus it can be concluded that there two potential extracts could be explored for further in vivo studies.

17

EFFECT OF CHRONIC EXPOSURE TO GSM 900/1800 MHZ RADIOFREQUENCY RADIATION ON GENERAL BLOOD PHYSIOLOGY AND REPRODUCTIVE FUNCTION IN MALE RATS

K. Chaithanya; Preeti. Kumari; Razdan. Rema; Devasani. Karan

Department of Pharmacology, Al-Ameen College of Pharmacy, Bangalore -560027, Karnataka, India.

Introduction: The long term interaction of mobile phone radio-frequency radiation (RFR) on general health, especially on male fertility and repercussion of above is becoming a major concern for current researchers for obvious reasons. Objective of the current study was aimed for evaluating the effect of long term exposure of RFR from mobile phones on blood pressure, hematological parameter, testosterone level, sperm count and their morphology. To perform the current study the RFR generator was used and a uniform radio frequency radiation with frequency range of 900 MHz and 1800 MHz were exposed to the rats placed individually in hexagonal plastic cage which is divided into six compartments. After the experimental period, blood pressure, hematological parameter, testosterone level, sperm count and their morphology were studied .Total sperm count, their morphology, total platelet count were significantly affected at both RFR. BP, neutrophil, lymphocyte percentage were significantly affected at 900 MHz however no significant changes were observed in hemoglobin content, total RBC and WBC count, eosinophil percentage and serum testosterone level.Hence it can be concluded that a long term (12week) mobile phone RFR exposure significantly affected hematological parameter, and had perilous effect on male fertility in rats.

18

SEMI SOLID DOSAGE FORMS MANUFACTURING: TOOLS, CRITICAL PROCESS PARAMETERS, STRATEGIES, OPTIMIZATION AND RECENT ADVANCES

Md. Amman Maqbool*, Manoj Kumar Mishra, Supriya Pathak, Adarsh Kesharwani, Anuradha Kesharwani

Shambhunath Institute of Pharmacy, Jhalwa, Allahabad, Uttar Pradesh-211012, India.

The objective of present study was to document the requirements for manufacturing of semisolid dosage forms. These guidelines also brief about some issues associated with tools, strategies, critical process parameters and strategies of the manufacturing and validation processes specific to semisolid dosage forms. Studies about the effect of manufacturing processes and formulation exipients on the rheology of semisolids have contributed significantly toward their characterization. The development of computer-assisted instruments also has contributed substantially to their characterization and thereby to improving their quality. Variations in the manufacturing procedure that occur after either of these events are likely to be critical to the characteristics of the finished product. This is especially true of any process intended to increase the degree of dispersion through reducing droplet or particle size (e.g., homogenization). Semisolids can adhere to the application surface for sufficiently long periods before they are washed off. This property helps prolong drug delivery at the application site. Novel semisolids are non-greasy since they are made up of water washable bases. Hence they cause less irritation to skin and are superior to conventional semisolid dosage form. The major conclusion drawn from such detailed study of semisolids in –process shortfalls provides a better vision and encounter while designing and developing new formulations.

19

ENHANCED ORAL BIOAVAILABILITY OF NEBIVOLOL HYDROCHLORIDE THROUGH LIQUISOLID APPROACH: APPLICATION OF NOVEL EXCIPIENTS

Narender Naik G1*, Shaym Sunder R2

1Jyothishmathi Institute of Pharmaceutical Sciences, Karimnagar, India.

2University Institute of Chemical Technology, Osmania University, Hyderabad, India.

Nebivolol hydrochloride is a selective ?1- antagonist falls under class II biopharmaceutical classification system. In the present investigation liquisolid compaction approach is applied to improve the dissolution and permeability properties thereby enhancing the oral bioavailability of nebivolol hydrochloride. Different formulations were developed by dissolving the drug in mixture of Transcutol HP & Propylene glycol (Non volatile liquid; 1:1 ratio), converting this liquid medication using fujicalin and neusilin as carriers and syloid FP 244 as coating material. In vitro drug release profiles of liquisolid compacts shown enhanced drug release when compared to pure drug as well as marketed formulation. The plasma concentration-time profile of healthy wister rats indicated that the oral bioavailability of optimized formulation has been significantly improved when compared to pure drug and marketed formulation. Improved bioavailability might be due to increased wetting properties of drug and improved permeability of the drug due to lipophilic properties of solvent used for wetting. From this study we can conclude that liquisolid technique is one of the promising alternative techniques to improve the bioavailability of class II drugs.

20

FORMULATION DEVELOPMENT AND EVALUATION OF MUCOADHESIVE MICROSPHERES OF ORAL HYPOGLYCEMIC DRUG

Talat Farheen*1, Azmat Shaikh1, Dr. Zahid Zaheer1, Dr. Sadhana Shahi2

1Y.B. Chavan College of Pharmacy, Department of Pharmaceutics, Aurangabad-431001, Maharashtra, India.

2Government College of Pharmacy, Department of Pharmaceutics, Aurangabad-431005, Maharashtra, India.

Mucoadhesive microspheres were found to be more efficient for controlled drug delivery. Mucoadhesion ensures increased contact time of the dosage form with the absorption site while microspheres sustained the release of drug from the dosage form at the site of absorption and result into improved bioavailability of drug. The present study involves formulation and evaluation of mucoadhesive microspheres of oral hypoglycemic drug, metformin hydrochloride. The microspheres were formulated by emulsification phase separation technique using chitosan as polymer and gluteraldehyde as cross-linking agent. Preformulation studies showed that the compositions are compatible with each other. The formulation batches were prepared by 32 factorial design with two independent parameters, polymer to drug ratio and stirring speed. All the batches were evaluated for particle size, flow properties, mucoadhesion, microencapsulation efficiency, drug release and stability. The formulation MF5 showed nearly spherical microcapsules, good flowability, microencapsulation efficiency, mucoadhesion, stability and extended drug release upto 12 hours. An approach to develop a stable mucoadhesive microspheres of oral hypoglycemic drug, Metformin hydrochloride has been successfully achieved.

21

INCIDENCE OF ADVERSE DRUG REACTIONS IN GERIATRIC PATIENTS IN A TERTIARY CARE HOSPITAL

Neena Baby*1, Neetha Sabu1, Lubna Sulthana1, Navya Sunil1, V.Lalitha2, T.Sivakumar1, Arun Pandiyan S3

1Nandha College of Pharmacy, Erode, Tamil Nadu, India.

2Department of Pharmacology, Nandha College of Pharmacy, Erode, Tamil Nadu, India.

3Clinical Pharmacist Kovai Medical College Hospital Coimbatore, Tamil Nadu, India.

Drugs offer great benefit to elderly patients, but they may result in great risks when not administered or managed properly and also due to pharmacodynamics and pharmacokinetic changes. To estimate the incidence of ADR among elderly population and also to monitor the causality, preventability and severity of ADRs. The study was a prospective observational study carried out in a tertiary care hospital. The pertinent information was collected from patient IP files using a standard case record form and by enquiring about OTC medications and other drugs taken by them. All data were analyzed with the help of SPSS version 16 software. Out of 320 patients (55 had ADR) incidence of the ADRs was found to be 17.18 %. Majority of ADRs were type A reactions (50.90 %). Chi-square test was used for analysis and p value less than or equal to 0.05 was considered as significant. The study concluded by stating that involving clinical pharmacist services in patient care can significantly help to identify, resolve, and prevent the drug related problems in hospital thereby enhancing the patient outcomes.

22

INSILICO ACTIVITY PREDICTION OF DIAZEPINES DERIVATIVES

P. Navya Krishna*

Dept. of Pharmaceutical Chemistry, Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune, Maharashtra-411044.

The term psychosis is very broad and can mean anything from relatively normal aberrant experiences to the complex and catatonic expressions of schizophrenia and bipolar type-1 disorder1. Many targets for the treatment of psychosis are available namely NMDA receptor antagonists, Ketamine and MK-801, peptide deformylase, Acetylcholinesterase, G protein-coupled receptors, glutamate synthase (NADPH). The Protein-Ligand interactions plays a significant role in structural steroid hormones glutamate synthase (NADPH) Acetylcholinesterase, G protein-coupled receptors, transforming based drug designing. In our Present research work we have chosen glutamate synthase2 (NADPH) and Acetylcholinesterase3 as targets to screen our proposed chemical structures for anti-psychotropic activity. The molecules were docked to the above said targets and the energy values obtained are as follows using the docking software. Depending on the energy values we have chosen the best two drug analogs they are Compound 3e {-9.4}, Compound 3k {-10.0}. We tried to improve the binding efficiency and steric compatibility. Several modifications were made to the probable functional groups which are interacting with receptor molecules. Analogs of this drug molecule were prepared using ACD-chem.-sketch and docking. The modified drugs was sketched using chem.-sketch were found to be better than the conventional drugs available.

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VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF FIMASARTAN IN PRESENCE OF DEGRADATION PRODUCTS

Charu P. Pandya, Dr. Sadhana J.Rajput*

Quality Assurance Laboratory,Center of Relevance and Excellence in Novel Drug Delivery Systems, Faculty of Pharmacy, Shri. G.H. Patel Building, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara-390002, Gujarat, India.

A simple, isocratic, specific and sensitive stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of fimasartan in synthetic mixture. Fimasartan is used to treat hypertension. Reverse phase chromatography was performed on Shimadzu LC-20AD pump (binary) and Shimadzu PDA-M20A Diode Array Detector using Hypersil BDS C18 column (250 x 4.6 mm, 5?m) mobile phase containing Phosphate buffer pH3 :Acetonitrile (50:50, v/v) with a flow rate of 1ml/min. Detection was done at wavelength 262nm. Linearity was observed in the concentration range of 5-30?g/mL (R2=0.999) with regression equation y=78487x+66095. The LOD was found to be 1.54?g/ml and LOQ was found to be 4.67?g/ml. Fimasartan was subjected to stress conditions such as acidic, alkaline, oxidation, photolysis and thermal degradations. The proposed method was validated as per ICH guideline and was found to be accurate, precise and specific. The degradation products peaks were well resolved from the standard drug peak and hence this method can be used for quality control of fimasartan. The drug showed significant degradation in alkaline and oxidative condition. Degradation products in alkaline and oxidative conditions were identified by LC-MS. Oxidative degradation followed first order kinetic. Degradation rate constants and half -lives were determined.

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AUTHENTICATION OF AYURVEDIC MEDICINE TRIKATU CHURNA USING NEAR INFRARED SPECTROSCOPY - A NOVEL APPROACH

Kumaravelu C1,2, Gopal A1, Ram Krishna Rao Mudiganti3*, Ravi A1, Singh Sanjay Kumar3, Shil Sampad3

1CSIR - Central Electronics Engineering Research Institute- Chennai Centre, CSIR Madras Complex, Chennai - 600 113, India.

2Sathyabama University, Chennai, 600 119, India.

3Bhartath Institute of Higher Education and Research, Bhartath University, Chennai, 600 073, India.

During the recent past, several Ayurvedic medicines have been prepared and investigated with respect to physio-chemical standardization, pharmacological effects, safety, efficacy, cultivation of medicinal plants and manufacturing practices. The objectives of this study is suggesting a novel method for the authentication of Ayurvedic and Siddha medicines to ensure the identity, quality, purity and detection of adulterants non-destructively using the spectroscopic techniques. The Ayurvedic sample Trikatu Churna, TC, taken for analysis, is a polyhedral formulation of finely powered dried fruits of Piper nigrum, pn, Piper longum, pl, and rhizome of Zingiber officinale, zn, at equal proportions. The customised TC was prepared by mixing at the equal proportion of the pure and dried raw material component powders (reference sample). The NIR spectral characteristics of customised samples were compared with the market samples (test samples) by developing a suitable Chemometric model. Accordingly, a method is proposed using Principal Component Analysis (PCA) technique to bring out strong patterns from their reference TC spectra to validate test samples by identifying its identity, quality and purity non-destructively.

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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ELIGLUSTAT USING RP-HPLC METHOD IN BULK AND PHARMACEUTICAL DOSAGE FORM

Amena Tazeen1*, Dr. R. Vani2, Dr. M. Sunitha3

1Department of Pharmaceutical Analysis and Quality Assurance, Shadan Women’s College Pharmacy, Hyderabad, India.

2Department of Pharmaceutical Analysis, Shadan Women’s College Pharmacy, Hyderabad, India.

3Principal of Shadan Women’s College Pharmacy, Hyderabad, India.

In RP-HPLC method, the conditions were optimized to obtain an adequate separation of eluted compounds. Initially, various mobile phase compositions were tried, to separate title ingredients. Mobile phase and flow rate selection was based on peak parameters (height, tailing, theoretical plates, capacity or symmetry factor), run time and resolution. The mobile phase containing mixture of 0.1% OPA (pH-3): Acetonotrile (30:70v/v) with a flow rate of 1.5 ml/min is quite robust. The optimum wavelength for detection was 260 nm at which better detector response for both the drugs was obtained. The retention time of Eliglustat was found to be 2.144 min. To ascertain its effectiveness, system suitability tests were carried out on freshly prepared stock solutions. The calibration was linear in concentration range of 84 to 420 ?g/ ml, with regression 0.9979. The low values of % R.S.D indicate the method is precise and accurate. The mean recoveries were found above 100.53 % for the drug. The Method was checked by doing validation according to the ICH guidelines. Hence the method is validated and it is used for the routine analysis of Eliglustat in its pharmaceutical dosage form by RP-HPLC.