In-vitro Comparative Study Different Brands of Tenegliptin and Metformin HCl Prolonged Release Tablets by UV Spectroscopy

Abstract

Evaluation of the quality control standards of different generic brands of Teneligliptin & Metformin HCl extended-release tablets has been compare with the innovator Glucophage XR^®. The objective of this study is to determine the dissolution data by using f1 & f2.In this dissolution test following general method using 6.8 pH phosphate buffer volume 1000 ml at 100 rpm, USP I apparatus and also by using UV spectrum at 232nm. The uniformity of weight for the Six brands of this tablet with values that compiled with I.P specification and deviated less than 5% from the mean value. Using hardness tester, the strength of the tablets determined. Hardness of the tablets was in the range of 5.60±0.13 - 7.98±0.18kg/cm2 with all brands. The result of tablet friability test of all brands tested with friability values of 0.110% to 0.821% w/w. According to I.P. no batch having friability value > 1%w/w. This study concludes the physicochemical characteristic of six brands of this tablet complied with the official IP specification for hardness, friability, weight variation and dissolution. F1 and f2 factor provide uniformity in five brands of this tablet and analysis suggest that the Ingola M brand fails the test.