Indo American Journal of Pharmaceutical Research

ISSN NO.: 2231-6876
September 2012

RP-HPLC and chemometric assisted UV-spectrophotometric methods for simultaneous in vitro analysis of atrovastatin calcium, ezetimibe and fenofibrate in their pharmaceutical formulation

Abhishek Pathak, Sadhana J Rajput*, Rahul S Gamit

Pharmaceutical Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Shri G H Patel Pharmacy Building, Pharmacy Department, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara-390 002, Gujarat, INDIA.


One RP-HPLC and two chemometric assisted UV spectrophotometric methods were developed and validated for the simultaneous in vitro analysis of Atrovastatin calcium (ATV), Ezetimibe (EZET) and Fenofibrate (FEN) in their pharmaceutical preparation and ternary mixtures. The chromatographic separation was achieved on a reversed-phase, Hypersil BDS C8 column (250X4.6 mm i.d, 5 particle size) with a mobile phase consisting of methanol and 0.05M phosphate buffer (pH-6.3 adjusted with sodium hydroxide) in the ratio of (85:15)% v/v. The total run time was 7 min. Quantitation was achieved with UV detection at 248nm based on peak area. Linearity was observed over concentration range of 5 - 12μg mL-1 for ATV and EZET and 80 - 192 μg mL-1 for FEN. The two chemometric methods applied were inverse least square (ILS) and classical least square (CLS). These approaches were successfully applied to quantify each drug in their mixture using the information included in the UV absorption spectra of appropriate solutions in the wavelength range 220-310nm with the intervals of 5nm (Δλ = 5nm) at 19 wavelength points. For the chemometric calibration, 18 ternary solutions were prepared as training set and 10 ternary solutions were prepared as validation set. The developed methods were successfully applied for laboratory prepared mixtures as well as commercial tablet formulation for ATV, EZET and FEN concentration. The results obtained for pharmaceutical formulation by ILS and CLS methods were compared with isocratic HPLC method and a good agreement was found.


Formulation and Evaluation of Lipid Based Nanoemulsion of Glimepiride using self-emulsifying Technology

Meghana S. Kamble*, Varsha G. Borwandkar, Suraj S. Mane, Omkar R. Mane, Pravin P. Aute, Dr. Pravin D. Chaudhari

PES Modern College of Pharmacy, Sector No. 21, Yamunanagar, Nigdi, Pune-411044, Maharashtra, India.


The aim of the present study was to develop and optimize Self nanoemulsifying drug delivery system (SNEDDS) of glimepiride and convert to solid Self nanoemulsifying drug delivery system (S-SNEDDS). For screening purpose the solubility of glimepiride in various oils (Lipids), surfactants and co-surfactants was determined to select a suitable combination of these ingredients. Emulsification efficiency was determined and also pseudo-ternary phase diagrams were constructed. From the results of screening, four formulation variables were selected X1 Caproyl®90 (Lipid), X2 Cremophor®EL (Surfactant), X3 Capmul® MCM (Lipid) and X4 Simulsol® (Co-surfactant) and D-optimal mixture experimental design was applied to optimize SNEDDS of glimepiride. Eleven formulations were prepared and evaluated for drug release, % transmittance and globule size. The optimal formulation F9 was composed of glimepiride (2%), Caproyl®90 (20.8%), Capmul® MCM (15.6%w/w), Cremophor® EL (49.5%), Simulsol® 1292 (14% w/w) which was converted to S-SNEDDS using spray drying in presence of Aerosil® 200 Pharma. The spray dried particles of S-SNEDDS of glimepiride showed good flow properties. The drug content of S-SNEDDS, drug release, % transmittance and globule size were found to be 96.00%, 95.00%, 98.00% and 22.4 nm respectively. The S-SNEDDS of glimepiride showed drug release 99.03 % over 79 % drug releases from marketed product in 60 minutes. From the result s obtained S-SNEDDS could be promising to improve oral efficacy of glimepiride.



*Mahitha Boggula, Rajalakshmi Rukmangathen, Padmaja Chimmiri, Noor Ahmed, Chandra Mouli Yerram, Rubia yasmeen Balambigari, Amaravati.Vikram Sree Vidyanikethan College of Pharmacy, A.Rangampet, Tirupati, 517102, Andhra Pradesh, India.


The main goal of present work is to design a colon specific drug delivery of Tramadol hydrochloride multiparticulate systems by using sodium alginate and pectin polymers. Beads are coated with eudragit polymer for achieving colon specific by combining both pH and polymer based drug delivery. Pectin sodium alginate beads were prepared by ionotropic gelation method by using calcium chloride as cross linking agent. Coating is carried out by oil in oil solvent evaporation method. Particle size analysis, entrapment efficiency, scanning electron microscopy studies, swelling studies and Invitro dissolution studies were carried out. The optimized formulation was used for determining the analgesic activity by using eddy’s hot plate technique and tail flicking method. The % drug release was highest for the formulation TCB1 i.e. 93.2% and the controlled release was shown by the formulation TCB9 i.e. 74%. Biological evaluation was carried out and the percentage increase in reaction time was found to be 81.3% for the eddy’s hot plate method and the tail flicking latency time was found to be 93.13% for the optimized formulation (TCB9). It suggests that the optimized formulation showed increased resistance than the standard. The studies had clearly indicated that Tramadol hydrochloride through the pectin sodium alginate beads were very effective to deliver the drug specifically to colon.



*Rubia Yasmeen Balambhaigari, Prasanna Raju Yalavarthi, Jayasri Vulava, Harini Chowdary Vadlamudi and Rahul Nair

Sree Vidyanikethan College of Pharmacy, A.Rangampet, Tirupati, 517102, Andhra Pradesh, India.


The aspiration of present work is to design a colon specific drug delivery of mefenamic acid (MA) by using modified pulsincap technique and hupu gum as hydrogel. Mefenamic acid being poorly water soluble drug, solubility has been increased by solid dispersion technique using natural gums such as guar gum (GG), hupu gum (HG) and xanthan gum (XG). Solid dispersions were prepared by kneading method at different weight ratios of 1:1, 1:2 and 1:3 of MA and selected polymers. Saturation solubility, pH dependent solubility, phase solubility and dissolution studies were conducted. The optimized solid dispersions have been used for the formulation of pulsincaps. Bodies were made insoluble by formaldehyde treatment. Solid dispersions of mefenamic acid were filled in the bodies. Hupu gum (HG) was used as plug. Sealing of body and cap were done using ethyl cellulose. Ethyl cellulose coating was employed to ensure the colon targeting of pulsincaps. % drug release of MA pulsincaps prepared with MA and solid dispersions of MA-GG, MA-HG and MA-XG was found to be 41.25, 91.44, 93.87and 88.4 respectively. The studies have clearly indicated that mefenamic acid in pulsincap formulations were very effective to deliver the drug specifically to colon.


Formulation and Evaluation of Taste Masked Fast Dissolving Tablets of Risperidone by using Kyron T-104

Nilesh M. Ghuge1*, Amit Bhople, Anup R. Thakre, Bharati V. Bakade, Madhuri A. Channawar, Anil V. Chandewar, Pawan V. Bang

Department of Pharmaceutics, P.Wadhawani College of Pharmacy, Yavatmal, Maharashtra, India.
Corresponding author


Risperidone, a benzisoxazole derivative, is an atypical antipsychotic drug with high affinity for 5-hydrotryptamine (5-HT) and dopamine D2 receptors. It is used primarily in the management of schizophrenia, inappropriate behaviour in severe dementia and manic episodes associated with bipolar I disorder. But this drug has bitter taste which may leads to patient’s non compliance. Ion exchange resins are water–insoluble, cross–linked polymers containing salt forming groups in repeating positions on the polymer chain.1 It can be used in the drug formulations to stabilize the sensitive components, sustain release of drug, disintegrate tablets and mask taste. Kyron T-104 is Ion exchange resin. Aim of this research work was to develop mouth dissolving tablet that disintegrates rapidly in mouth by using tasteless complex of Risperidone and Kyron T-104. Effect of different parameters such as swelling time, resin activation, drug resin ratio as well as stirring time was optimized by taste and percentage drug loading. Formulated DRC (Drug Resin Complex) was characterized by infrared spectroscopy. Tablets were formulated by direct compression with Kyron T-314 as super disintegrants. In these batches optimum hardness was achieved but disintegration time was found to be 20 second. Tablets formulated with 10% Kyron T-314 showed comparatively low disintegration time (20 sec), and friability (0.60 %) than the other batches. In present study we optimized the conditions required for maximum drug loading of Risperidone with Kyron T-104. Among different superdisintergants was found suitable with drug-resin complex to get the low disintegration time and friability of tablets.



1Dr. K.V.Subba Reddy Institute Of Pharmacy, Dupadu, Kurnool, Andhrapradesh.
2Vinayaka Missions College of Pharmacy, Salem, TamilNadu.
3Kamalakshi Pandurangan College of Pharmacy, Tiruvannamalai , Tamil Nadu


Transdermal drug delivery systems (TDDS) are dosage forms designed to deliver a therapeutically effective amount of drug across a patient’s skin. In the current research Diltiazem hydrochloride was loaded in transdermal patch and they are prepared by solvent casting method using aluminum foil as the backing membrane. Eudragit RS100 and HPMC were weighed in requisite ratios and they were then dissolved in methanol as solvent using magnetic stirrer.Four optimized transdermal patches were formulated with different drug-polymer ratios. Diltiazem Hcl (20mg) was added into homogenous dispersion under slow stirring with a magnetic stirrer. Dibutyl phthalate 30%w/w of polymer composition was used as plasticizer, added to the above dispersion under continuous stirring. Invitro and physico-chemical evaluation methods were performed. Finally F3 formulation showed higher drug release (83.4 %),thickness (0.45±0.04), weight (532.6±0.36), folding endurance(5),drug content(86.23±0.08)%MC (4.66±0.04),%MA (8.24±0.75),%ML (3.97±0.02),WVTR(2.07±0.01) and drug permeation (1173 μg/ml) than the remaining formulations. Hence, F3 can be selected as best formulation among the four optimized formulations.


Proteomics Tools for Oral Cancer Biomarker Discovery

Nishant Sharma1,2*, Dr .B.R Srivastav1 and Dr. Archana Shrivatav2

1Cancer Hospital and Research Institute Gwalior India 2 College of Life Sciences Gwalior India


Proteomic study of human body fluid (saliva and serum) holds assure as a non-invasive method to identify biomarkers for human oral cancer. The evolving of novel technologies allows researchers to aid the inclusive analyses of proteomes in cancer. The protein expression pattern of tumors cells measure by proteomics technologies that provide opportunities to discover potentially new biomarkers for the early detection and diagnosis of oral cancer. Different proteomic tools such as 2DPAGE, 2D-DIGE,MALDI, SELDI-TOF-MS LC-MS/MS technology, protein arrays, iTRAQ, ICAT and MudPIT have been used for discrepancy analysis of various biological samples, including cell lysates, Saliva, serum, plasma and tumors tissue to better understand the molecular foundation of cancer pathogenesis and the validation and characterization of disease-associated proteins. This review covers a selection of advances in the dominion of proteomics and its promise for oral cancer biomarker discovery. It also introduces sample preparation and discusses current challenges that need to be defeat and the efforts of the Early Detection of oral cancer and promoting biomarker discovery for conversion at the clinical level.