Comparative in Vitro Equivalence Evaluation of Some Aceclofenac Generic Tablets Marketed in Bangladesh

Availability of copious generic brands in local drug market makes the health professionals confused to select the desired quality product. This study was designed to assess the bioequivalence of six generic Aceclofenac tablets from different manufacturers using in vitro dissolution study in order to minimize health risk factors. Other general quality assessments of these tablets like diameter, thickness, hardness, friability, weight variation, disintegration time were also evaluated according to the established protocols. Using a validated UV spectrophotometric method, active ingredients were assayed. All brands complied with the official specification for weight variation and disintegration time but only two brands complied in case of friability. Assay value was recorded within 92.68% to 100.51%. The dissolution profiles showed intra brand and inter brand variability. Only three brands achieved 80% dissolution within 60 minutes. Test results were subjected to statistical analysis to compare the dissolution profile. Model independent approaches of difference factor (f1) and similarity factor (f2) were employed and the data revealed that only two brands may be used interchangeably. Such study serves as a good cursor for assessment of in vitro parameters of commercially available products.