METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN BY RP-HPLC

Abstract

A simple, precise and RP-HPLC method was developed and validated for the simultaneous determination of Dapagliflozin (DAP) in pharmaceutical dosage forms. The separation was achieved on an Inspire (4.6 x 150mm, 5μm)5micro column with isocratic flow. The mobile phase at a flow rate of 1.0mLmin consisted of Methanol and Water (80:20, v/v). The UV detection was carried out at 235nm. The retention times for DAP were 4.422 min, respectively. Parameters such as linearity, precision, accuracy, specificity and ruggedness are studied as reported in the International Conference on Harmonization guidelines. A linear response was observed over the concentration range of 50-90μg/ mL for DAP. Limit of detection and limit of quantification for DAP were 2.98. The analysis concluded that the method was selective for Dapagliflozin which will help to improve quality control and contribute to stability studies of pharmaceutical tablets containing these drugs.