Assessment of Quality Control Parameters of Two Brands (SiglitaTM, JanviaTM) of Sitagliptin Tablets Available in Bangladesh

Abstract

Assessment of Quality Control Parameters is always a better way for the understanding of the quality of local brands. Thus, the purpose of this research work was to determine the physical quality control parameter of two brands (JanviaTM 50 and SiglitaTM 50) of Sitagliptin tablets which is used for the treatment of type II diabetes. Thirty eight tablets from each brand were taken from the local market and the quality control parameters including weight variation, hardness, friability, disintegration test, dissolution test were determined. In weight variation test of SiglitaTM 50 tablets, the average weight was 0.1886 gm and the weight variation ranged from +3.833% to −3.088%. JanviaTM 50 tablets had the average weight of 0.2246 gm and the weight variation ranged from +3.778% to -1.282%. All the tablets of SiglitaTM 50 and JanviaTM 50 showed a percentage weight variation within the range of ±5% specified in the USP. In friability test, friability of SiglitaTM 50 tablet was 0.8%. The friability of Janvia TM 50 was 0.53%. All the tablets of both brands SiglitaTM 50 and JanviaTM 50 have met the USP specification and passed the friability test. In this research study, the average hardness of SiglitaTM 50 and Janvia TM 50 were 1.835 kg/cm and 2.465 kg/cm respectively. Hardness of tablets of both brands was below the acceptance range but these tablets met the acceptance range in friability test. Less hardness can cause breakdown of tablets during use and transport. The disintegration time of six tablets of SiglitaTM 50 and JanviaTM 50 were obtained as 1 min 12.17 sec and 1 min 37.83 sec respectively and met the specification of USP. In comparative study on dissolution profile of innovator brand (Januvia) and local brands of Sitagliptin, the difference factor (f1) was found 2.992% for SiglitaTM 50 and for JanviaTM 50 it was 2.536%. In case of similarity factor (f2) the values were 67.676% and 65.695% for SiglitaTM 50 and JanviaTM 50 respectively. These values ensure pharmaceutical equivalence of the two products.