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Abstract

An accurate, precise, specific and rapid RP-HPLC method was developed and subsequently validated for the determination of Dapagliflogin in API. Better separation of the drug was achieved on BDS column (250×4.5mm, 5µ) with a mobile phase consisting of a mixture of ortho phosphoric acid and acetonitrile (45:55 v/v) at a flow rate of 1ml/min, with detection at 245nm using Photo Diode Array (PDA) detector. The developed method was validated for different parameters such as linearity, accuracy, precision, limit of detection(LOD), limit of Quantitation (LOQ), robustness and the results were found to be within the limits according to ICH (International Conference on Harmonization) guidelines. The retention time was found to be 2.963 min. The method was found to be linear in the range of 25-150µg/ml with a correlation coefficient (r2) of 0.999. The LOD and LOQ of the method were calculated to be 0.6 and 1.8µg/ml respectively. The Precision was estimated by employing repeatability; intra-day and inter-day studies and the results were calculated as %RSD values and were found to be within the limits. The average recovery of the analyte was found to be 99.8% which confirms the accuracy of the method.