Method Development and Validation of Dapagliflozin Drug in Bulk and Tablet Dosage form by RP-HPLC
Journal Title: International Journal of Pharma Research and Health Sciences - Year 2017, Vol 5, Issue 4
Abstract
A new simple, rapid, efficient and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Dapagliflozin in Tablet dosage form. The separation was effected on a Symmetry C18, 25cm x 4.6mm i.d. 5μm, Particle size column using a mobile phase mixture of Methanol: ACN: %OPA in a ratio of 75:25:05 v/v/v at a flow rate of 1.0ml/min. The detection was maintained at 246nm. The retention time of Dapagliflozin was found to be 2.797minutes. The Dapagliflozin drug was linear in the concentration range of 0-70μg/ml. The method validation parameters were estimated and found in the limit according to ICH guidelines, which indicates the validation of the developed method. The developed method is also found to be simple, precise, accurate, specific, robust and rapid for the estimation of Dapagliflozin in bulk and tablet dosage form.
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