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Development and Validation of stability-Indicating RP-HPLC method for determination of Dapagliflozin


Manasa Sanagapati Dhanalakshmi K1 Nagarjuna Reddy G2 Sreenivasa S3

Abstract

The present study describes the development and subsequent validation of a stability indicating reverse phase HPLC (RP-HPLC) method for the analysis of Dapagliflozin in its API. The proposed method utilizes BDS column (maintained at ambient temperature), gradient run (using mixture of acetonitrile and ortho phosphoric acid as mobile phase), effluent flow rate (1ml/min) and detection at 245nm using PDA detector. The developed method was successfully validated for different validation parameters as per ICH guidelines. The stability of the drug was determined by studying the degradation of the drug under acidic, alkaline, peroxide, neutral, heat and UV conditions.



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