Quantitative Estimation and Validation of Dapagliflozin and Metformin Hydrochloride in Pharmaceutical Dosage form by RP-HPLC

摘要

A simple and more economic RP-HPLC method was developed and subsequently validated for the simultaneous determination of Metformin and Dapagliflozin in bulk and pharmaceutical dosage form. The chromatographic conditions were standardized using a Cosmosil C18 column with 250mm in length and internal diameter of 4.6mm with size 5p.m. The analyte detection was carried out by using a UV detector set at a wavelength of 228 nm. The mobile phase consisted of Methanol: Potassium dihydrogen phosphate buffer with pH 3.0 (80:20%v/v) and retention time of Metformin and Dapagliflozin was found to be 3.6 min and 5.2 min respectively. The calibration curves of two drugs were linear with correlation coefficients of 0.999 and 0.998 over a concentration range of 100-500ug/ml for Metformin and l-5ug/ml for Dapagliflozin. This method has been validated and shown to be accurate, precise, specific, sensitive, linear, robust and fast. Metformin and Dapagliflozin were subjected to different degradation stress conditions. The degradation products were well resolved from that of pure standard drugs (Metformin and Dapagliflozin) with significant different retention time values. The current method has been statistically validated according to the ICH guidelines and this method has been subsequently developed and applied successfully to determine the levels of Metformin and Dapagliflozin in a combined formulation and in the routine quality control analysis with good accuracy and sensitivity.