Abstract

Bisoprolol fumarate is a selective β-1 blocker and is useful in the management of cardiovascular diseases. According to Biopharmaceutical Drug Classification System, it is a class I drug, which has high solubility and permeability. In this study, five brands of bisoprolol fumarate 10 mg tablets that are marketed in Aden, Yemen, have been evaluated using dissolution test with the aim to assess bioequivalence of the generic products B, C, D and E with the innovator product A. A high Performance Liquid Chromatographic method was used for the analysis of bisoprolol fumarate in the tablets. The method was validated for the parameters like system suitability, linearity, limit of detection and limit of quantification. The dissolution test was performed according to the United States Pharmacopoeia-30 (USP-30) for the five brands and the obtained dissolution profiles data of the four generic brands were subjected to comparison with the innovator brand using difference factor f₁, similarity factor f₂ and dissolution efficiency. The results of the method validation revealed its suitability for quantification of bisoprolol in the tested tablets. The five brands contain between 97.52%-102.43% of the labeled amount of bisoprolol fumarate and released more than 80% of drug within 30 minutes, which were within the USP acceptance criterion. The calculated f1, f2 and DE indicated that the generic brands, except brand E, were bioequivalent to the innovator and could be used as generic substitutes for the innovator brand.