COMPARATIVE ASSESSMENT OF THE QUALITY CONTROL MEASUREMENTS OF MULTISOURCE AMLODIPINE TABLETS MARKETED IN NIGERIA

Abstract

The aim of this study was to evaluate some quality control parameters to assess the quality, safety and efficacy of six brands of amlodipine tablets marketed in Nigeria. The physiochemical parameters and assay of the six brands of amlodipine were assessed through the evaluation of uniformity of tablet weight, friability, hardness, disintegration, and assay of active ingredients according to established methods. The dissolution rate and disintegration time were determined in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) without enzymes. The dissolution efficiency (DE) and predicted availability equivalence (PAE) of the various brands were used to estimate their likely in-vivo bioavailability. The dissolution profile showed that none of the samples attained 70% dissolution in 45 minute in SGF and SIF while only samples A and E in 1 hour in SGF There was no significant difference in the mean values of the DE for the products in SGF and SIF in the range 0.33-0.41 and 0.32-0.43 respectively (p=0.2). Significant difference exists between the values of T70 of the products in both SGF and SIF (p 0.5). Products E and A (innovator) are equivalent and demonstrate comparable quality standards. The method is simple and rugged for evaluation of quality control parameters of amlodipine for consistent batch to batch production of generic product.