ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF METFORMIN AND SITAGLIPTIN IN BULK AND TABLET DOSAGE FORM BY RP-HPLC

A new RP-HPLC method for the quantitative determination of Metformin and Sitagliptin was developed and validated as per ICH guidelines. The drugs were injected into Kromasil C18 (4.6 x 250mm, 5µm), maintained at ambient temperature and effluent monitored at 254 nm.The mobile phase consisted of OPA (0.1%) : Acetonitrile (40% : 60% ) The flow rate was maintained at 1.0 ml/min. The calibration curve for Metformin and Sitagliptin were linear from 125-7500µg/ml and 12.5-75µg/ml respectively (r2 for Metformin = 0.999,r2 for Sitagliptin = 0.999).The proposed method was adequate, sensitive, reproducible, accurate and precise for the determination of Metformin and Sitagliptin in bulk and tablet dosage form. Keywords: Metformin and Sitagliptin, Validation