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THE PHARMA REVIEW (JAN FEB 2019)

Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin in Pure and Pharmaceutical Dosage Form

V. Rajani1*, Y. Rajendra Prasad2 & A. Lakshmana Rao3

Introduction:

Abstract: Combination of Dapagliflozin and Saxagliptin has been successfully used for the treatment of diabetes mellitus. The objective of the present study was to establish a simple, precise, specific and stability indicating RP-HPLC method for the simultaneous estimation of Dapagliflozin and Saxagliptin in bulk and tablet dosage form. The analysis has been performed on Agilent BDS column (250 x 4.6 mm, 5) at 30C using water:acetonitrile (50:50, v/v) as mobile phase. The detection was carried out at 210 nm with a flow rate of 1.0 ml/min. The retention time of Dapagliflozin and Saxagliptin was found to be 3.172 min & 2.583 min respectively. The linearity range was 25-150 g/ml for Dapagliflozin and 1.25-75 g/ml for Saxagliptin respectively. The forced degradation studies were performed as per the guidelines of ICH under acidic, alkaline, oxidative, thermal, photo stability & neutral conditions. The developed method was successfully validated for all the parameters and was found to be within the limits. The developed method could be successfully employed for the simultaneous estimation of Dapagliflozin and Saxagliptin in pure and tablet dosage form.

 

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