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ISSN 2063-5346
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SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND ITS IMPURITIES IN TABLET DOSAGE FORM

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B. Akhila, B V Ramana
» doi: 10.53555/ecb/2023.12.12.328

Abstract

A new stability- indicating analytical method by LC-MS/MS was developed for the simultaneous determination of dapagliflozin and its synthesis impurities. A LC-MS/MS model was used for method development and validation. The separation was achieved in a column (50 x 3.0 mm, 1.8 μm), using a mixture of acetonitrile: water (70:30, v/v) as mobile phase in isocratic mode. The method was properly validated according ICH guidelines with respect to linearity, specificity, precision, accuracy and robustness. The calibration curves of each analyte showed determination coefficients (r2) and the method was linear at the concentrations ranges for dapagliflozin and its impurities. Lastly, this method presented low limits of detection (LOD) and quantification (LOQ) for both dapagliflozin and impurities, being a technique with high sensitivity.

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