Development and Validation of an RP HPLC Method for Analysis of Sitagliptin

Sitagliptin is a drug used against type 2 diabetes mellitus and it is 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 Sitagliptin in bulk formulation. The max of the Sitagliptin was found to be 267nm in Methanol phosphate buffer 10mM pH 4.8 60 40 v v . The method shows high sensitivity with linearity 10 to 50µg ml regression equation y = 45765x 239272 r2 = 0.9996 . The various parameters according to ICH guidelines and USP are followed for validating and testing of this method. The Detection limit and quantitation limit were found to be 0.743 µg ml-1 and 2.25µgml-1 respectively. 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 Sitagliptin in bulk and pharmaceutical formulation. Pradnya Lokhande "Development and Validation of an RP-HPLC Method for Analysis of Sitagliptin" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-6 , October 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29214.pdf Paper URL: https://www.ijtsrd.com/chemistry/analytical-chemistry/29214/development-and-validation-of-an-rp-hplc-method-for-analysis-of-sitagliptin/pradnya-lokhande