ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF METFORMIN AND VOGLIBOSE IN BULK AND FIXED DOSE COMBINATION (TABLETS) BY RP-HPLC

A new RP-HPLC method for the quantitative determination of Metformin and Voglibose was developed and validated as per ICH guidelines. The drugs were injected into Hypersil BDS C18 column (250×4.6, 5 µm), maintained at ambient temperature and effluent monitored at 236 nm.The mobile phase consisted of 0.02M KH2PO4: Acetonitrile (50:50 V/V). The flow rate was maintained at 1.0 ml/min. The calibration curve for Metformin and Voglibose were linear from 50-300µg/ml and 0.3-0.18µg/ml respectively (r2 for Metformin = 0.997,r 2 for Voglibose = 0.998).The proposed method was adequate, sensitive, reproducible, accurate and precise for the determination of Metformin and Voglibose in bulk and pharmaceutical dosage forms. Keywords: Metformin and Voglibose, Validation.