Second-derivative synchronous spectrofluorimetric assay of dapagliflozin: Application to stability study and pharmaceutical preparation.

Abstract

A highly accurate, simple and sensitive spectrofluorimetric analytical method for dapagliflozin (DGF) quantitation was developed. The proposed method was successively applied to DGF analysis in both its pure and pharmaceutical dosage forms. This method was developed to investigate DGF stability in its degradation products, as laid out in International Council for Harmonisation (ICH) rules. Kinetics of alkaline degradation of DGF was also calculated. The half-life time (t1/2 ) of the reaction was 75.32min. An alkaline degradation pathway was described. The present study involved measurement of the second-derivative synchronous fluorescence intensity of DGF at Δλ=30nm. Peak amplitude was measured at 322nm. Linear range of the calibration curve was 0.1-1.0μgml-1 . Lower detection and quantitation limits were 0.023 and 0.071μgml-1 , respectively, and indicated good sensitivity of the proposed method. Mean per cent recovery was 99.78±1.78%. The proposed analytical approach was successfully applied to DGF in the quality control laboratory and would be suitable as a stability-indicating assay.