BIOANALYTICAL METHOD DEVELOPMENT AND （分析方法开发、）.pdf

Academic Sciences International Journal of Pharmacy and Pharmaceutical Sciences Academic Sciences ISSN- 0975-1491 Vol 4, Issue 3, 2012 Research Article BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF VILDAGLIPTIN A NOVEL DIPEPTIDYL PEPTIDASE IV INHIBITOR BY RP-HPLC METHOD A. B. PHARNE2 1 3 2 1 , B. SANTHAKUMARI *, A. S. GHEMUD , H. K. JAIN , M. J. KULKARNI 1Department of Center for Materials Characterization, National Chemical Laboratory, Dr. Homi Bhabha Road, Pune 411008, Maharashtra, India, 2Department of Pharmaceutical Chemistry, CYMET’s Siddhant College of Pharmacy, Pune- 412109, Maharashtra, India, 3Department of Pharmaceutical Chemistry, Sinhgad College of Pharmacy, Vadagaon (BK) Pune, 411041, Maharashtra, India. Email: b.santhakumari@ncl.res.in Received: 05 Nov 2011, Revised and Accepted: 25 Dec 2011 ABSTRACT A simple, selective, rapid, precise and economical Reverse-Phase HPLC method has been developed and validated for quantitative determination of vildagliptin in plasma. Vildagliptin is a potent dipeptidyl peptidase IV inhibitor used for treatment of diabetes. Tolbutamide is used as an internal standard. The method was carried out with UV Spectrophotometric detection using a Perkin Elmer Series 200 HPLC system equipped with XBridge Shield C18 column (3.5 µm, 4.6×150mm) and a guard column of the sam