Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin in marketed formulation
Simple, precise and accurate UV-Spectrophotometric simultaneous equation method for estimation of dapagliflozin (DAPA) and saxagliptin (SAXA) were developed and validated as per ICH guidelines. This Method involves solving of simultaneous equations based on measurement of absorbance at two wavelengths 222 nm and 276 nm (λmax of SAXA and DAPA) in phosphate buffer pH 6.8. Both the drugs obey the Beer’s law in the concentration ranges 5-25µg/ml. % Recovery for both the drugs were in the range of 98.44-99.05% indicating excellent accuracy. The methods were precise, with a relative standard deviation of less than 2% for both drugs. The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus, method can be used for routine monitoring of drugs in industry for the assay of bulk drugs and commercial formulation (QTERN tablets, Astra Zeneca).
Keywords: Dapagliflozin, Saxagliptin, Spectrophotometric analysis, Simultaneous equation method.
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