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Abstract

COMPARATIVE IN VITRO PHARMACEUTICAL EQUIVALENCE STUDIES OF DIFFERENT BRANDS OF ATORVASTATIN CALCIUM TABLETS MARKETED IN BANGLADESH

Md. Abir Khan, Abu Asad Chowdhury, Nur Jaharat Lubna*

The main target of the present study was to evaluate the pharmaceutical equivalence of atorvastatin calcium tablets of five brands marketed in Bangladesh using in vitro dissolution study. The dissolution was carried out using the apparatus II according to USP guidelines. Evaluation of physicochemical parameters such as content uniformity test, weight variation analysis, and hardness, friability and disintegration test was carried out according to United States of Pharmacopoeia. All brands complied with the official specification for content uniformity test, weight variation, hardness, and friability and disintegration time. Despite the inter brand and intra brand variability of dissolution profiles of the atorvastatin tablets, three out of five brands attained more than 75% dissolution within 45 minutes. For comparative analysis of dissolution, a model independent approach of similarity factor (f2) was used. The results showed that three brands of atorvastatin calcium tablets out of five passed all the pharmacopoeia tests for satisfactory quality. Thus, only these can be interchanged in clinical practice.


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