Analytical Method Development and Validation of Teneligliptin by using RP HPLC with ICH Guidelines

Teneligliptin is drug used against type 2 diabetes mellitus and it is also a member of class of anti diabetic drugs known as dipeptidyl peptidase 4 inhibitors or gliptins . A simple, sensitive and accurate RP HPLC method has been developed for the determination of Teneligliptin in bulk formulation. The max of the Teneligliptin was found to be 246 nm in Methanol Phosphate buffer pH 3 70 30 v v . The method shows high sensitivity with linearity 10 to 50 µg ml regression equation y = 54647x 74133 r2 = 0.9968 . The various parameters according to ICH guidelines are followed for validating and testing of this method. The Detection limit and quantitation limit were found to be 0.109 µg ml –1 and 0.3305 µg ml–1 in Methanol Phosphate buffer pH 3 70 30 v v respectively. The purity of tablet formulation was found to be 99.57 . The results demonstrated that the procedure is accurate, specific and reproducible RSD 2 , and also being simple, cheap and less time consuming and appropriate for the determination of Teneligliptin in bulk and pharmaceutical formulation. Dr. Pradnya Lokhande ""Analytical Method Development and Validation of Teneligliptin by using RP-HPLC with ICH Guidelines"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-3 , April 2019, URL: https://www.ijtsrd.com/papers/ijtsrd21735.pdf Paper URL: https://www.ijtsrd.com/chemistry/chromatography/21735/analytical-method-development-and-validation-of-teneligliptin-by-using-rp-hplc-with-ich-guidelines/dr-pradnya-lokhande