IAJPR

Indo American Journal of Pharmaceutical Research

ISSN NO.: 2231-6876
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FEBRUARY 2014
1

SPECTROPHOTOMETRIC DETERMINATION OF LEVETIRACETAM USING 2, 4-DNP IN PHARMACEUTICAL DOSAGE FORM

Sai Thanuja V, R S Chandan*, B M Gurupadayya, Prathyusha W, M Indupriya

Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS University, Mysore 570 015, (KA), India

Abstract

A simple, extraction free spectrophotometric method for the quantitative estimation of levetiracetam (LEV) in bulk drugs and pharmaceutical formulations (tablets) has been developed. The method is based on the oxidation of 2, 4- dinitrophenylhydrazine (2, 4-DNP) and coupling of the oxidized product with drugs to give intensely colored chromogen. Levetiracetam at its λmax 455 nm shows linearity in the concentration range of 30-130 µg mL-1. The relative standard deviation for this method is 0.422%. Linear relationship with good correlation coefficients (0.995-0.996) was found between absorbance and the corresponding concentrations of the drug. The reliability and performance of the proposed method was validated statistically the percentage recovery ranged from 99.88 and 100.2. The results of analysis for this method have been validated statistically and by recovery studies.

2

A STUDY ON SYNERGISTIC ANTIOXIDANT ACTIVITY OF SOME TROPICAL LEAFY VEGETABLES

Srikanth Nyamthabad*, M.Umesh

Ganga Pharmacy College, Das Nagar, Nizamabad, Andhrapradesh.

Abstract

Green leafy vegetables (GLV) consumption has been reported to contribute to lowering the risk of age-related cataract. These are known to contain antioxidants necessary in neutralizing free radicals which are known human chemical hazards.Green leafy vegetables have been identified as good sources of natural antioxidants such as tocopherols, vitamin C and polyphenols which are responsible for maintaining good health and protect against coronary heart diseases and cancer. GLV are the major sources of lutein and, in developing countries where access to animal food is restricted, contribute substantially to fighting retinol deficiencies by being rich sources of the provitamine A, β-carotene, not withstanding bioavailability issues.In the present study evaluation of synergistic antioxidant activity of extract from Ocimum gratissimum, Vernonia amygdalin and Alternanthera sessilis were carried out. Synergistic antioxidant activity of the leaf extract were carried out using DPPH, H2O2 and Nitric oxide scavenging assay at 100 µg/mL and 200 µg/mL and compared with the standard Ascorbic acid. In the present study, extract showed a significant effect in inhibiting DPPH, reaching up to 85.00% (Combined extract) at concentration of 200 µg/mL. The extract showed a significant effect in inhibiting H2O2, reaching up to 84.00 % (Combined extract) at concentration of 200 µg/mL. The extract showed maximum activity of 85.00 % (Combined extract) at 200 µg/mL, where as ascorbic acid at the same concentration exhibited 94.96% inhibition in Nitric oxide scavenging assay.

3

EVALUATION OF ANTIDIABETIC ACTIVITY OF TOMATO (SOLANUM LYCOPERSICUM) SEED EXTRACT

Srikanth Nyamthabad*, M.Umesh

Ganga Pharmacy College, Das Nagar, Nizamabad, Andhrapradesh

Abstract

Dry seeds of the fruits of the plant, Solanum lycopersicum (family:  Solanaceae), are highly valued in traditional medicine in the treatment of various human diseases, including diabetes mellitus and obesity. In the present study, the hypoglycaemic and weight loss effects of 50 - 200 mg/kg of the aqueous seed extract of Solanum lycopersicum (SL) were investigated in normal and drug-induced hyperglycaemic rats. In addition, the acute oral toxicity using the preliminary and the main tests of the Up-and-Down Procedure according to OECD/OCDE Test Guidelines on Acute Oral Toxicity was conducted. Phytochemical analysis of the aqueous seed extract was also carried out. Results showed that SL caused progressive and significant (p<0.05, p<0.01 and p<0.001) dose-related reduction in the blood glucose concentrations in normal and drug-induced hyperglycaemic rats. SL also caused significant (p<0.05 and p<0.01) dose-dependent reduction in the average body weight of treated rats when compared to untreated rats.  Results of the phytochemical analysis of SL revealed the presence of alkaloids, flavonoids, tannins and glycosides.

4

COMPARISON OF THE %DRUG RELEASE OF DRUG AND POLYMERS (PVP K30 AND PEG 6000) BY USING VARIOUS BUFFERS

NANSRI SAHA1*, Y.KRANTHI KUMAR2

1Dept. of Pharmaceutics, SSJ College of Pharmacy, V.N.Pally, Gandipet, Hyderabad - 500 075, Andhra Pradesh, India.

2Department of Quality Assurance, SSJ College of Pharmacy, V.N.Pally, Gandipet, Hyderabad - 500 075, Andhra Pradesh, India.

Abstract

Solid dispersions (SDs) of etravirine (ETR) were prepared with the objective of dissolution enhancement by solvent evaporation technique by using polymers like PEG 6000 and PVP (k30).  In vitro dissolution studies of SDs performed in 0.1 N HCl and pH 6.8 phosphate buffer solution showed a significant increase in dissolution rates of ETR comparing to physical mixtures and pure drug. Comparatively, SD of ETR: PEG 6000 and ETR: PVP (K30) in various weight ratios (1:2, 1:4, 1:6) were prepared by solid dispersion method exhibited a higher release rate than the conventional method. Improved dissolution of model drug may be attributed to the modification in drug crystalline in SDs as was evident from our analytical studies. The dissolution pattern of the ETR from all the SDs followed predominantly, first order kinetics. This study reflects the vital role of polymers as a novel approach to improve the solubility of ETR, which could minimize the variable dissolution rates with increase in bioavailability.

5

SPECTROPHOTOMETRIC DETERMINATION OF LAMOTRIGINE USING BM REAGENT IN PHARMACEUTICAL DOSAGE FORM

Prathyusha W, R S Chandan*, B M Gurupadayya, Sai Thanuja V, M Indupriya

Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS University, Mysore 570 015, (KA), India

Abstract

Simple, extraction free spectrophotometric method for the quantitative estimation of Lamotrigine (LMT) in bulk drugs and pharmaceutical formulations (tablet) has been developed. It is based on the diazotization of drug with nitrous acid, to form diazotized compound, followed by its coupling with N-(1-naphthyl) ethylene- diamine dihydrochloride [Bratton-Marshall reagent] to form a violet colored compound. Lamotrigine at its λ max of 464 nm shows linearity in the concentration range of 50-350 µg/ml. The relative standard deviation for Lamotrigine is 0.308% was obtained. Linear relationship with good correlation coefficients (0.998) was found between absorbance and the corresponding concentrations of the drug. The reliability and performance of the proposed method was validated statistically the percentage recovery ranged from 100.1% and 99.7%. The result of analysis for the method has been validated statistically and by recovery studies.

6

PREPARATION AND EVALUATION OF OCULAR INSERTS OF TIMOLOL MALEATE USING ISOLATED STARCH FROM RAW BANNANA: IN VITRO EVALUATION

Nansri Saha*1, Soumik Ghosh2

1SSJ college of pharmacy, Vattinagulapally, Gandipet, Rangareddy (Dist), Hyderabad, AP – 500075)

2Hetero Labs ltd, Formulation Research & Development (Oncology), Jadcharla, Hyderabad - 509302

Abstract

Matrix type of ocular insert was prepared using starch isolated from un-ripped bannana in different concentration by solvent casting method. The compatibility study of drug and polymer was performed by FTIR. Physicochemical evaluations like weight variation, thickness, content uniformity, moisture absorption, moisture loss test were performed. In vitro release study was carried out for all formulations and overall results revealed that as concentration of starch increases there was slow release of Timolol maleate occurred from the formulation.  It proved that drug and polymer are compatible to each other; there was no interaction between drug and excipients.  The weights of all inserts were found to be in the range of 32.29 to 7.63 mg with least standard deviation.  The thickness of the prepared insert varies from 0.063 to 0.099 mm.  The drug content of all the formulation was found to be in the range of 98.11 to 99.40 %.  The surface pH of the prepared inserts varied between 7.2 to 7.4, which is comparable with the pH of tear fluid i.e. 7.4.  The folding endurance of all the formulations was found to be good.  Moisture absorption of prepared formulations was found to be in the range of 4.41 to 7.51 %.  Moisture loss of prepared formulation was found to be in the range of 2.00 to 4.89 %. The in vitro release of drug from the different ocular insert was studied using the classical standard cylindrical tube fabricated in the laboratory (bi-chambered donor receptor compartment model).  It was observed that almost 100 % drug released from all formulations occurred at the end of 180 to 300 minutes. Fast release of drug from formulation F1 occurred may be due to low concentration of starch. The overall result revealed that as the concentration of starch increases there was slow release of drug from formulation occurred

7

COMPARISON OF ESSENTIAL OILS COMPOSITION AND ANTIOXIDANT ACTIVITIES OF ARTEMISIA JAPONICA THUNB. AND A. NILAGIRICA(CLARKE) PAMP.

Pradeep D.P, Meenu Krishnan V.G, Lubaina A.S, Remya Krishnan & Murugan K*

Plant Biochemistry and Molecular biology Laboratory, Department of Botany, University College, Trivandrum 695 034, India

Abstract

Artemisia species are used in traditional medicine for the treatment of various ailments such as indigestion, infection, irregular menstruation, cramp, cold, epilepsy, typhoid, tuberculosis, urinary calculi, colic, fever, asthma, bronchitis, sciatica, flatulence, anaemia, insomnia, gout, depression, nervousness, hysteria, measles, bruise, chilblain, leprosy, malaria and cancer. Similarly, most species has been used as antiseptic, antioxidant, anthelmintic, expectorant, diuretic and insect repellent.  The biological activity shown by the plants was due to the essential oil present in them. The present study describes the fractionation of essential oil and its antioxidant potentialities in two allied species - Artemisia japonica Thunb. and A.nilagirica (Clarke) Pamp. The essential oil from Artemisia japonica and A.nilagirica was isolated by hydrodistillation and analyzed by GC-MS. 30 and 19 compounds were noticed in the oil respectively. The predominant phytocomponents in the essential oil of A.nilagirica were camphor (41%), 8-Cineole (17.0%), Borneol (8.6%) Artemisia ketone (6.4%) and β-Thujone (6.0%). Meanwhile A. japonica contain Linalool (70.4%), Caryophyllene oxide (6.7%), trans-Linalool oxide (4.5%), p-cymene (3.4%) and 1, 8-Cineole (2.3%). Significant antioxidant potentialities was displayed in terms of  DPPH scavenging, beta carotene bleaching, total antioxidant activity, soybean oil rancidity and sun flower oil free fatty acids and iodine values. Interestingly, A.nilagirica showed remarkable antioxidant potentialities and was comparable with synthetic antioxidants such as ascorbate, butylated hydroxytoluene and BHA. The present study suggests that the tested Artemisia species revealed a pool of potential biomolecules in the essential oil and also exerted remarkable antioxidant values. Further studies are warranted to isolate and purify the principle component from the essential oil.

8

FORMULATION AND EVALUATION OF RAMIPRIL TRANSDERMAL MATRIX FILM FOR TREATING HYPERTENSION

D.Vazram1, S.Duraivel1, K.P.Sampath Kumar2, Debjit Bhowmik3*,  Rajalakshmi. A.N4     

1Nimra College of Pharmacy, Vijayawada, Andhrapradesh.

2Department of Pharmaceutical Sciences, Coimbatore Medical College, Coimbatore.

3Karpagam university, Coimbatore.

4Mother theresa post graduate and research institute of health sciences, Puducherry

Abstract

Transdermal drug delivery system is being extensively investigated as a viable alternative to drug delivery with improved bioavailability. The aim of the present investigation is to develop membrane type Transdermal drug delivery patches of antihypertensive agent Ramipril. Transdermal patches of Ramipril were prepared by using polymers, like HPMCK15M, Ethyl Cellulose and PVPK30. The patches were transparent, smooth and flexible. The results of weight variation, thickness, moisture content, moisture uptake, Folding Endurance, Tensile strength, drug content with the range. The patches were evaluated by DSC and SEM to ensure compatibility of drug with polymer and . The optimized formulation R5 is 96.42% drug release after 24 hours uniform distribution of the drug.

9

SOLUBILITY AND DISSOLUTION RATE ENHANCEMENT OF ITRACONAZOLE BY SOLID DISPERSION TECHNIQUE

SOLUBILITY AND DISSOLUTION RATE ENHANCEMENT OF ITRACONAZOLE BY SOLID DISPERSION TECHNIQUE

Mahesh Kumar Kataria*1, Anil Bhandari1

1Research Scholar, Faculty of Pharmaceutical Sciences, Jodhpur National University, Jodhpur (Rajasthan) INDIA.

2Professor & Dean, Faculty of Pharmaceutical Sciences, Jodhpur National University, Jodhpur (Rajasthan) INDIA.

Abstract

Itraconazole, a potent antifungal drug, is a poorly water soluble drug and belongs to BCS class II. The objective of the research work was to formulate and optimize solid dispersions (SDs) of a poorly water soluble drug, itraconazole, with sodium starch glycollate, croscarmellose sodium, eudragit E-100 for the enhancement of the solubility and dissolution rate of the drug. Solid dispersions were prepared by solvent evaporation techniques in different weight ratios of polymers. The physical mixtures and solid dispersions were subjected to drug content and dissolution test. The dissolution was enhanced greatly in the itraconazole with croscarmellose sodium (1:7 ratio). The best formulation, itraconazole with croscarmellose sodium in 1:7 ratio, among all was further adsorbed on neusilin US2 in 1:1 ratio by milling for almost 10min to form ternary mixture. The tablet dosage form prepared from ternary mixture was stable at stressed conditions 40±2°C and 75±5% RH. The release kinetics of drug from formulation and marketed product follows first order release. The similar factor f2 was within limit for the product at stressed conditions with the product at room temperature at the same time. The increased dissolution rate was achieved by more than seven times and ten percent comparatively to the itraconazole API and marketed product respectively.

10

DISCOVERING POTENT INHIBITORS AGAINST THE ENOYL-ACYL CARRIER PROTEIN REDUCTASE (InhA) OF MYCOBACTERIUM TUBERCULOSIS: STRUCTURE-BASED DESIGN, SYNTHESIS AND ANTIMICROBIAL ACTIVITY OF QUINOLINE HYDRAZONES

S. D. Joshi1*, Uttam A. More1,2, Sheshagiri R. Dixit1, Deepak Dubey1, Avanish Tripathi1, V. H. Kulkarni1

1Novel Drug Design and Discovery Laboratory, Department of Pharmaceutical Chemistry, S.E.T’s College of Pharmacy, Sangolli Rayanna Nagar, Dharwad 580 002, Karnataka, India

2Centre for Research and Development, Prist University, Thanjavur 613 403, Tamil Nadu, India

Abstract

Enoyl-ACP reductases catalyze the final step in the elongation cycle of the bacterial fatty acid biosynthesis (FAS-II) pathway, has been recognized as a promising target for the development of new drugs for TB. Here we present the discovery of a quinoline class of compounds as inhibitors of this enzyme using a combined approach of rational selection of compounds for screening, analogue search and docking studies. Various arylhydrazides were added to 3rd position of the 2-chloro/2-methoxy-quinoline nucleus to evaluate their influence on the activity toward Mycobacterium tuberculosis H37Rv (MTB) and Staphylococcus aureus, Bacillus subtilis, Escherichia coli and Vibrio cholera. Structures of these compounds were established by FTIR, 1H NMR, 13C NMR and mass spectroscopy. The synthesized compounds showed a MIC range of antitubercular activity, extending from 0.2 to 3.125 µg/ml against M. tuberculosis H37Rv. Among the Schiff bases, compound 6b, 6c and 6e exhibited highest activity against the tested mycobacteria at a MIC of 0.2 µg/mL. Hydrogen bonding pattern and Cscore for compounds 4a-e, 6a-6e, 7a and 8a found satisfactory on enoyl ACP-reductase enzyme. Compounds showed promising inhibitory potency because of replacement of 2nd position chlorine atom with electron-donating methoxy group which can cause a compound to become less acidic. Analysis of the docking study provided details on the fine relationship linking structure and activity, and offer clues for structural modifications that can improve the activity

11

DESIGN, OPTIMISATION AND EVALUATION OF MUCOADHESIVE PERORAL IN SITU GEL CONTAINING ANTI FUNGAL DRUG FOR CANDIDIASIS

B. Prakash Rao 1* E.Hima bindu2 S.K.Uma Devi2 G.Rohini Reddy3 Sheena. M .Raj 3

Department of Pharmaceutical technology, Karnataka college of Pharmacy, Bangalore, Karnataka, India

2Department of Pharmaceutics, St.Pauls  college of Pharmacy, Hyderabad, Andhra Pradesh, India

3Department of Pharmaceutical analysis, St.Pauls  college of Pharmacy, Hyderabad, Andhra Pradesh, India

Abstract

The two factorial design was used to develop the controlled release mucoadhesive peroral in situ gel containing voriconazole as drug candidate. Carbopol 934P and hydroxy propyl methyl cellulose (HPMC E50) were taken as formulation factors (independent variables). Gelation time (R1), Mucoadhesive Strength (R2), drug release at 1 hour (R3), drug release at 8 hrs (R4), drug release at 12 hrs (R5), and Gel strength (R6) were taken as responses (dependent variables). The polymers had significant effect on gelation time, mucoadhesive strength, drug release at 8th hour. It was found that carbopol shows higher mucoadhesive strength than HPMC E50. Comparatively carbopol controls the drug release greater than that of HPMC E50. The n value of Peppas equation for optimized formula is 0.67 which indicates that optimized formulation follows non-Fickian release mechanism. The FT-IR and DSC studies indicate no physic-chemical interaction. Stability studies revealed that optimized formulation was stable. The predicted values of optimized formula like gelation time, mucoadhesive strength, drug release at 1 hr, drug  release at 8 hrs, drug release at 12 hrs,  and gel strength are 82 sec, 17150 dynes/cm, 23.2%, 64.1%, 91.1%, 52.0 sec respectively and the actual values found to be 82 sec, 17540 dynes/cm, 21.0%, 63.0%, 91.1%, 52 sec.

12

RAPID UPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SULFAMETHOXAZOLE AND TRIMETHOPRIM IN PHARMACEUTICAL DOSAGE FORMS

J. Srinivasa Rao1; vejendla.ravikumar2; Ravali Nacham2; Varnalatha Kachakayala2; Kalpana.K2

1Department of Pharmaceutical analysis, QIS College of Pharmacy, Ongole, Andhra Pradesh, India.

2Department of Pharmaceutical analysis, Sri Indu College of Pharmacy, Hyderabad, Andhra Pradesh, India.

Abstract

A  Rapid, isocratic UPLC method was developed and validated for simultaneous estimation of Sulfamethoxazole (SMX) and Trimethoprim (TMP) in Tablet formulation. The separation was selected by using a column with BEH C18 (50 x 2.1mm, 1.7µm) and further elution was also optimized using buffered mobile phase (0.1% v/v Phosphoric acid) and Acetonitrile as a modifier in a ratio of 14:86v/v, with a flow rate of 0.5 ml-1. This UV Detection of these compounds was monitored at 210nm. The retention times for Sulfamethoxazole (SMX) and Trimethoprim (TMP) were found to be 0.6, 1.5 min, respectively. The validation Results were found to be linear in the concentration range of 5-50 μg/ml for SM and 5-30 μg/ml for TP. The Intra-day and Inter-day variation, as RSD (%), was found to be <1.0%. The % Mean Recovery was found to be within 98-102%. The results showed, the method was demonstrated that this proposed UPLC method to be Specific, Linear, Precise, Accurate and Robust for simultaneous determination of SMX and TMP in combined dosage form.

13

SYNTHESIS AND BIOLOGICAL ACTIVITY OF NOVEL NITROGEN CONTAINING ANALOGUES OF PODOPHYLLOTOXIN

B.Umeshaa, Y.B.Basavaraju a,*, C.Mahendrab, S.B.Shivakumara, K. Poornachandra Raoc, M.H.Krishna a

aDepartment of Studies in Chemistry, University of Mysore, Manasagangotri, Mysore - 570 006, Karnataka, India.

bDepartment of Studies in Botany, University of Mysore, Manasagangotri, Mysore - 570 006, Karnataka, India.

cDepartment of Studies in Microbiology, University of Mysore, Manasagangotri, Mysore - 570 006, Karnataka, India.

 Abstract

A novel nitrogen containing analogues of podophyllotoxin 6a-d i.e., substituted 5-phenyl-4,5-dihydro-2H-benzo[g]indazoles were synthesized in high yields by the condensation of   hydroxylmethylene tetralones and hydrazine hydrate in absolute ethanol. The structures of the compounds were confirmed by IR, 1H-NMR, 13C-NMR, Mass spectral and elemental analysis data. The new compounds were evaluated for their antimitotic activity by onion root tip method and also antimicrobial activity against bacterial and fungal strains. The antimitotic activity was compared with control, compound 6d showed more potent inhibitions and compound 6c exhibited moderate inhibitions. The antimicrobial activity of the synthesized compounds were compared with standards, compound 6d showed excellent activity and compound 6c showed moderate activity against bacterial and fungal strains. In the antimicrobial activity, among the synthesized analogues 6a-d, compound 6d showed high activity against all the bacterial and fungal strains. Hence, compound 6d showed very good activity in both antimitotic and antimicrobial activity.

14

IN VITRO ANTIARTHRITIC ACTIVITY OF WITHANIA COAGULANS DUNAL FRUITS

Archana K. Shendkar*1, Sugandha G. Chaudhari 1, Yogesh K. Shendkar 2

1 Department of Pharmacology, Dr.L.H.Hiranandani College of Pharmacy, Ulhasnagar, District-Thane, India

2Department of Medicine, Virar Homeopathic Medical College, Virar, District-Thane, India

Abstract

The aim of the study was to investigate the anti-arthritic activity in methanolic and hydro alcoholic extracts of Withania Coagulans dunal fruits i.e. WCME and WCHAE by in vitro procedures in past. Phytochemical analysis has indicated presence of alkaloids, flavonoids, glycosides, steroids, saponins, fixed oil, carbohydrates. Both the extracts have showed anti-arthritic activity by Protein denaturation method, Membrane stabilization method, and Protienase inhibitory method in all various concentrations i.e. 50,100, 150, 200, 250µg/ml. The IC50 value of WCME, WCHAE and Diclofenac sodium (standard) was found to be 145.37µg/ml, 124.25µg/ml, 106.29µg/ml in case of membrane stabilization method, 127.41µg/ml, 103.24µg/ml, 87.14µg/ml in case of protein denaturation method and 166.4737µg/ml, 126.9737µg/ml, 94.5737µg/ml in case of proteinase inhibitory method respectively. Maximum inhibition of 68.80±2.262%, 72.01±3.565% and 79.5±5.35% at 250 µg/ml ml in case of membrane stabilization method, 70.59±7.02%, 75.51±6.59% and 80.99±6.379% in case of protein denaturation method and 65.72±6.94, 65.86±5.5 and 80.27±2.88%  in case of proteinase inhibitory method by WCME, WCHAE and Diclofenac sodium (standard) respectively. Both the extracts showed the good dose dependent activity in three of the in vitro models. But WCHAE showed the most significant anti-arthritic activity than WCME. The findings of the present study suggested that Withania Coagulans dunal fruits could be a potential natural source of anti-arthritic activity.

15

TO STUDY THE BIOREMEDIATION OF MONOCROTOPHOS AND TO ANALYZE THE KINETICS EFFECT OF TWEEN 80 ON FUNGAL GROWTH

Bhawana Pandey1, Priyanka Singh Baghel2 and  Shikha Shrivastava3

Department of Biotechnology and Microbiology, Bhilai Mahila Mahavidyalaya, Hospital Sector, Bhilai (C.G.), India.

Abstract

Biodegradation and bioremediation both are same processes which are based on the metabolism of pesticide and insecticides by microorganisms. Microorganisms which are used for the process of bioremediation are known as bioremediators.In this experiment we used an organophosphorus compound i.e. Monocrotophos (MCP) pesticide. Aspergillus fumigatus is one of the Aspergillus species to cause disease in human being with an immunodeficiency. Addition of Tween 80 stimulates the utilization of hexamer. When Aspergillus niger combined with Tween 80 this mixture effectively enhanced the solubility and degradation of MCP. Bioremediation of Monocrotophos at different concentration by using Aspergillus fumigatus and the kinetics effect of Tween 80 on fungal growth were studied and found that the A. fumigatus degrade the MCP till its 1% concentration.

 

16

ANALYTICAL DEVELOPMENT AND VALIDATION OF REVERSE PHASE LIQUID CHROMATOGRAPHY METHOD FOR ESTIMATION OF VALSARTAN IN BULK DRUG

Dr. Anita shinde1, Dr. Suman Malik2, Dr. K.C. Asati, Amit Asati2

1Department of chemistry I. E. H. E, Bhopal.

2Department of chemistry Sadhu Vaswani College Bairagarh, Bhopal.

Abstract

A simple, precise and reversed phase liquid chromatographic (RP-LC) method was developed and validated for estimation of valsartan in bulk drug. The separation was achieved on Acquity HSS T-3 1.8µ, (2.1 X 100) mm, Make: Waters, analytical column with mobile phase consisted of buffer (10mM Potassium dihydrogen phosphate with 0.05% triethylamine in water, adjust pH  3.0 with dilute phosphoric acid) : Acetonitrile (50:50v/v) at isocratic flow of 0.35ml/min with UV detection wavelength was at 205 nm and 3μl of sample volume was injected. The retention time of valsartan was found to be 1.9 minute. The method was successfully validated in accordance to ICH guidelines for accuracy, precision, specificity, linearity. The linear regression analysis data for calibration plots showed good linear relationship in the concentration range 25-75μg/mL for valsartan. The % Recovery/Accuracy was within the range between 98% and 102%. The percentage RSD for precision method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied