Evaluation of the quality control parameters of six brands of Esomeprazole (40 mg) tablets available in Bangladesh

Abstract

This study evaluated the quality control parameters of six brands of Esomeprazole 40 mg tablets marketed in Bangladesh. Here to assess their compliance with USP standards. Weight variation, hardness, friability, disintegration, and dissolution tests were performed on randomly selected samples from each brand. All brands complied with weight variation specifications (±5% deviation) and demonstrated excellent friability performance (<1% weight loss). Furthermore, hardness values ranged from 11.384 to 17.553 kg. This value exceeds conventional ranges due to the enteric coating requirements of Esomeprazole. However, critical concerns emerged in functional tests of disintegration. Two brands failed to disintegrate within 45 minutes. It may occur due to an overcoated material for enteric coating. During this study, no tablet brands achieved the required 75-80% drug release in dissolution testing. It may occur due to failure to maintain the standard laboratory procedure during lab work.