Abstract

COMPARATIVE BIOEQUIVALENCE STUDY OF DIFFERENT BRANDS OF VALSARTAN TABLETS MARKETED IN BANGLADESH BY DISSOLUTION MODELING AND QUALITY CONTROL TESTS

*Farzana Hasin, Sharja Noon, Hasib Al Hasan, Shamima Nasrin

ABSTRACT

Valsartan is an angiotensin II receptor antagonist (commonly called an ARB, or angiotensin receptor blocker), that is selective for the type I (AT1) angiotensin receptor. Valsartan is mainly used for treatment of high blood pressure, congestive heart failure, and to increase the chances of living longer after a heart attack. The objective of this study was to evaluate the suitable brand of Valsartan tablet having better dissolution profile, to evaluate study of physicochemical equivalence of different brands as well as to determine that which brand is economically as well as therapeutically effective for the patient of hypertension. Three brands (represents IMS-Health reported top to small scale companies) of Valsartan 80 mg were collected randomly from different pharmacies. Fore selected brands were coded as A, B & C. The different brands were evaluated for hardness, weight variation, disintegration, chemical assay and dissolution tests. Resul ts of different brands were found within in the limits. The chemical assay test of all the tablets showed that none had potency less than the required specifications of USP. The results of all the tests performed show that GMP and cGMP guidelines have been followed during manufacturing. This study proved the physicochemical equivalent of the four different brands. So if one brand is not available in the market than any of the other three brands can be taken in place of that unavailable brand according to the economic conditions of the patients.

Keywords: Valsartan, In-Vitro Dissolution, Disintegration Time, Physicochemical Equivalency.