Evaluation of Pharmaceutical Equivalence of Two Different Brands (Limaryl and Dactus) of Glimepiride Tablets (2mg) Available in Bangladesh

Abstract

An important aspect of the development of any pharmaceutical product is to maintain the quality standards of the product. This research work is aimed to investigate the pharmaceutical equivalence of two different brands of glimepiride (2mg) tablets available in the Bangladeshi market. In this study tablets of two batches of each brand (Limaryl and Dactus) were collected from local market. Quality control tests were performed for evaluation of hardness, thickness, weight variation, disintegration time, dissolution and potency of the tablets from each brand according to the specification of USP and BP. All the batches showed weight variation within the range of ±10% and thickness test was within acceptance limit in accordance of USP (±5%) . Hardness value of these two brands is within 2 kg, which is lower than standard range specified by USP (4kg). Less hardness may cause breakage of tablets during storage and transportation. Disintegration time of all the batches was within acceptance range of 15 minutes. All the batches had dissolution rate below the range and did not fulfill the specification. According to the BP and USP the acceptance level of percent potency of active drug lies from 100 ± 10% or 90- 110%.These two brands had the percent potency greater than the range. So, more batches of these two brands should be required to carry out the dissolution and potency test according to BP and USP. Friability test could not be carried out due to some mechanical defect in the instrument. So further research study should be convey on these two brands to check whether they meet the specification or not.