http://localhost:8080/xmlui/handle/123456789/7329 2026-04-05T15:30:28Z http://localhost:8080/xmlui/handle/123456789/7554 A Randomized, Open Lable, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Atorvastatin Calcium Tablet 80 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition. PATEL, CHIRAG Objective: The objective of present study was to carry out bioequivalence of Test Product: Atorvastatin Calcium 80 mg Tablet and Reference Product: Citalor (Atorvastatin Calcium 80 mg Tablet) of Pfizer Ireland Pharmaceuticals, under Fasting condition in normal, healthy, adult, human subjects, in a randomized, open label, crossover study. Experimental Work Done: Total 18 normal, healthy, adult, human subjects were enrolled. The subjects willingly signed the informed consent form before participating in the study. Single oral dose of test product or reference product was administered in each study period considering 07 days washout period. A total of 22 blood samples (5 ml each) were collected from the subjects during each study period. Analysis of plasma concentrations of Atorvastatin was done by a validated LCMS/MS analytical method. A non-compartmental method was used to calculate the pharmacokinetic parameters using drug concentration time profile. Statistical comparison of the pharmacokinetic parameters of both the formulations was performed to assess bioequivalence. Results And Discussion: In the study total 18 subjects were enrolled from which data of 17 subjects were analyzed and one subject was withdrawn due to vomiting. For test formulation versus the reference formulation, the least squares mean test/reference ratios of Ln(Cmax) and Ln(AUC0-t) were 96.59%,97.82%.The 90% confidence interval for logtransformed data of Test Product compared to that of the Reference Product was 83.59- 115.67% for Cmax and 82.63-115.79% for AUC0-t. In this study test formulation was found bioequivalent to the reference formulation as per predetermined regulatory criteria. Conclusion: Based on the statistical analysis of the results, it can be concluded that the Test Product Atorvastatin Calcium Tablet 80 mg is bioequivalent to the Reference Product in terms of rate and extent of absorption under fasting condition. As well as it is well tolerated and safe. For Full Thesis Kindly contact to respective Library 2012-05-01T00:00:00Z http://localhost:8080/xmlui/handle/123456789/7553 Formulation and evaluation of bilayer tablet of diclofenac sodium and ranitidine hydrochloride BHADANI, RONAK The aim of this investigation is to prepare Bilayer tablet containing diclofenac sodium and ranitidine hydrochloride, where diclofenac sodium will be in the sustained release layer and ranitidine hydrochloride is in the immediate release layer. Ranitidine hydrochloride was formulated as immediate release layer using sodium starch glycolate(3%, 4%, 5%), cross carmellose sodium (3%, 4%, 5%) as superdisintegrants and evaluated for physical parameter and disintegration time. The optimized ranitidine hydrochloride immediate release layer contained sodium starch glycolate (5%) showed the least disintegration time of 1.12 min and highest drug release of 99.10% 45 min was selected. Diclofenac sodium was formulated as sustained release layer using different polymer matrix like HPMC K 100M (15%, 20%) and HPMC K 4 M (15%, 20%) and combination containing HPMC K 100M (9.77%, 10.77%, 12.55%) and HPMC K 4 M (4.71%, 8.22%, 8.37%) evaluated for physical parameter along with in vitro release studies. The optimized sustained release layers contained HPMC K 100M (12.55%) and HPMC K 4 M (8.37%) with highest drug release of 99.21% for 10 hr was selected. Finally bilayer tablets were prepared by single compression of optimized diclofenac sustained release layer and ranitidine hydrochloride immediate releasing layer. Bilayer tablets were evaluated for hardness, thickness, weight variation, friability and drug content. Diclofenac causes acidity in stomach and ranitidine decrease the acidity related to diclofenac. Hence bilayer tablets of ranitidine hydrochloride and diclofenac sodium as immediate and sustained release combination could be used to improve patient compliance towards the effective management of inflammation along with acidity and gastritis. For Full Thesis Kindly contact to respective Library 2020-05-01T00:00:00Z http://localhost:8080/xmlui/handle/123456789/7547 Development and validation of analytical method for simultaneous estimation of etizolam and propranolol hydrochloride in bulk and its formulation Rana, Nirav An Absorption ratio Method and RP-HPLC methods were developed and validated for simultaneous estimation of Etizolam and Propranolol Hydrochloride in bulk and synthetic mixture. A simple and easy UV spectrophotometric method with good sensitivity has been developed for simultaneous quantification of Etizolam and Propranolol Hydrochloride. The method employed Absorption ratio method based on the measurement of absorbance at two wavelengths, 249 and 264.03 nm, λmax of Etizolam and Isobestic Point, respectively. The calibration curve was linear in a concentration range of 1-6 μg/ml for Etizolam and 40-160 μg/ml for Propranolol Hydrochloride. The RP-HPLC method has shown adequate separation of Etizolam and Propranolol Hydrochloride in bulk and its synthetic mixture. The separation was achieved on a Nova-pack C18 (150mm X 4.6 mm i.d., 4 μm particle size) With an isocratic system of Phosphate buffer (pH): ACN at pH 5 in the ratio of 60:40 v/v. The mobile phase at a flow rate of 0.75 ml/min, Injection volume 20μl and wavelength of detection used was 264 nm. The retention time for Etizolam and Propranolol Hydrochloride was obtained as 4.33±0.1min and 8.83±0.2min, respectively. The linearity of the proposed method was investigated in the range of 0.5-3μg/ml and 20-120μg/ml for Etizolam and Propranolol Hydrochloride, respectively. Correlation coefficient was 0.9988 and 0.9998 for Etizolam and Propranolol Hydrochloride, respectively. The developed method was validated as per ICH guideline, for its accuracy, precision, LOD & LOQ and the results were found to be satisfactory, thus the method is specific, rapid and simple with good sensitivity for estimation of Etizolam and Propranolol Hydrochloride. These analytical methods are also applicable in ordinary laboratories. It can also be adopted for quality control tests for these drugs in tablets. For Full Thesis Kindly contact to respective Library 2013-05-01T00:00:00Z http://localhost:8080/xmlui/handle/123456789/7545 Development and Validation of Analytical Method for The Simultaneous Estimation of Montelukast sodium and Desloratadine in Bulk and In Their Tablet Dosage Form Patel, MohmmedAfzal A simple, accurate, precise and stability Indicating RP-HPLC method was developed and validated for simultaneous estimation of Montelukast sodium and Desloratadine in bulk and in their tablet dosage form. The RP-HPLC method has shown adequate separation for Montelukast sodium and Desloratadine from its degradation products. The separation was achieved on a Hypersil BDS C18 (250mm X 4.6mm i.d., 5μm particle size) with an isocratic mixture of phosphate buffer : Methanol pH 3.5 adjusted with orthophospharic acid in the ratio of 60:40 v/v. The mobile phase at a flow rate of 1.0ml/min, Injection volume 20μl and wavelength of detection was kept at 246nm. The retention time for Montelukast A simple, accurate, precise and stability Indicating RP-HPLC method was developed and validated for simultaneous estimation of Montelukast sodium and Desloratadine in bulk and in their tablet dosage form. The RP-HPLC method has shown adequate separation for Montelukast sodium and Desloratadine from its degradation products. The separation was achieved on a Hypersil BDS C18 (250mm X 4.6mm i.d., 5μm particle size) with an isocratic mixture of phosphate buffer : Methanol pH 3.5 adjusted with orthophospharic acid in the ratio of 60:40 v/v. The mobile phase at a flow rate of 1.0ml/min, Injection volume 20μl and wavelength of detection was kept at 246nm. The retention time for Montelukast For Full Thesis Kindly contact to respective Library 2013-05-01T00:00:00Z