A New RP-HPLC Method Development and Validation of Dapagliflozin in Bulk and Tablet Dosage Form

A new, simple, selective, accurate, rapid and precise reversed-phase high-performance liquid chromatographic technique of Dapagliflozin was established as per ICH Guidelines. RP-HPLC was performed on a Waters C18, 5 µm particle size, 25 cm × 4.6 mm i.d., with phosphate buffer and acetonitrile in the ratio of 60:40 v/v as a mobile phase and a flow rate of 1.0 ml min-1. UV detection was performed at 237 nm. Total run time was 6.0 min. The retention time of Dapagliflozin was found to be 3.461 minutes. Validation of the developed method was done as per USP and ICH guidelines. Method validation revealed that the method is rapid, accurate, precise, reliable, and reproducible. Linear calibration plots were obtained in the concentration range of 10-60 µg/ml for Dapagliflozin. Limit of detection were 0.02 µg/ml and limit of quantification were 0.06 µg/ml for Dapagliflozin. The high recovery and low coefficients of variation confirm the effectiveness of process in the dosage form. The validated method was successfully used for quantitative analysis of commercial available tablets.

Author(s):

Jitendra Debata, Sundeep Kumar, Sajal Kumar Jha and Amjad Khan

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