Evaluation of the Quality Control Parameters of Two Different Brands of Sitagliptin 50 mg Tablet available in Bangladesh

Abstract

The aim of this study was to evaluate the physicochemical parameters of two different market brands of Sitagliptin 50mg tablet that are from different pharmaceutical companies of Bangladesh. The drugs were obtained from the local drug shops. The tablets used were Sitagil® of Incepta pharmaceuticals Ltd; Sliptin® of Drug International Ltd & Januvia of Marc & Co. The quality control parameters including weight variation, hardness, friability, disintegration test, dissolution test were performed to evaluate the tablets and to get a comparison between these marketed products. As Sitagliptin is an INN drug it has no specific dissolution method in USP or BP. So, a dissolution method listed by USFDA (United States Food & Drug Administration) was followed. Both brands (Sitagil® and Sliptin®) were complying with the official tests. For Sitagil® hardness was 4.2-5.1kg/cm, weight variation ranged from +0.899 to 0.905%, friability was 0.166%, and disintegration time within 1.44 min. The dissolution study of Sitagil® showed similarity factor 57.7% & dissimilarity factor 3.9% in comparison to the innovator brand Januvia. For Sliptin® hardness is (5.1-5.9kg/cm), weight variation (+0.898 to0.902%), friability (0.182%), and disintegration tests within 1 minute. But dissolution study of Sliptin® could not be done due to some technical problems. Quality control parameters of tablet are useful tools for better quality of medicines. It is important for maintaining consistency in batch-to-batch manufacturing and it should be performed for every drug product. Various results were obtained from the test and compared with the specification. All the tablets met the specification and, hence, it can be concluded that the tablets of the local brands had the desired and optimum therapeutic efficacy.