Analytical Method Development and Validation of Dapagliflozin By RP-HPLC Method In Tablet Dosage Form

The main aim of the present research work is to develop a sensitive, precise and accurate HPLC (High-Performance Liquid Chromatography) procedure for the selective estimation of Dapagliflozin. An isocratic separation of Dapagliflozin through column used was a Inertsil ODS-3V with dimensions of 150 mm length and 4.6 mm inner diameter, packed with 5μm particle utilizing mobile phase composition of Acetonitrile and Water, with a proportion of 50% Acetonitrile and 50% water (v/v).  The detection of the analyte was processed at the maximum wavelength of 223 nm and with 1 ml/min flow of the mobile phase. In the developed reversed-phase high-performance liquid chromatography (RP-HPLC) method, the analytes were separated using an isocratic program. The separation was performed on an HPLC system data acquisition and analysis was handled using  EZ-Chrome Elite Software. The results of the analysis were verified for linearity, accuracy, precision, robustness, limit of detection, and limit of quantification in the developed method. Five variable concentration levels of 1, 5, 10, 12.50 and 15.0 μg/ml were used for the estimation of recovery and linearity. The %RSD was also under 2%, demonstrating the great degree of precision of the suggested approach.