Quality and Pharmaceutical Equivalence Determinations of Commercially Available Amlodipine Besylate Immediate Release Tablets

Abstract

Counterfeit and substandard drugs possess serious health risk s . Regular quality screening is very important to ensure the standard and efficacy of pharmaceutical products. The study aimed to compare the quality of a mlodipine besylate tablets available in the Bangladesh drug market and examine their physical and pharmaceutical equivalence. The various physico-chemical parameters such as diameter, shape, size, weight variation, thickness, hardness, loss on drying (LOD), friability, disintegration, dissolution , and assay have been determined according to the methods mentioned in the United States Pharmacopoeia (USP) and British Pharmacopoeia (BP). Four brands of a mlodipine b esylate were purchased from different local retail stores and coded as ALT 1 , AMT 2 , AMT 3 , and AST 4 on the basis of their market share. All four brands met official USP specifications. Pharmaceutical equivalence was determined from the dissolution profile which gives acceptable difference ( f 1 ) and similarity ( f 2 ) factor values for all the brands compared with the benchmark brand for its highest market share. All the brands also met the USP criteria for assay of not less than 90.0% and not more than 110.0% of the labeled amount of a mlodipine (C 20 H 25 N 2 O 5 Cl).