New spectrofluorimetric analysis of empagliflozin in its tablets and human plasma using two level full factorial design.

Abstract

An efficient, accurate and sensitive spectrofluorimetric method was developed for analysis of empagliflozin (EGF) in pure form, dosage form and human plasma. The proposed procedure was based on formation of yellow fluorescent product between benzofurazan reagent and empagliflozin in slightly alkaline medium that is measured at 521nm, when excitation at 455nm. The present study was validated according to ICH guidelines and bioanalytical validated according to US-FDA guidance. The fluorescence intensity-concentration plot was linear over the range of 50-1000ngml-1 with limit of detection (LOD) and quantitation (LOQ) of 15.55 and 46.63ngml-1, respectively. The correlation (r) and determination (r2) coefficient was 0.9998 and 0.9997, respectively. Due to high sensitivity and selectivity of the proposed method, it is successfully used for analysis of empagliflozin in its dosage form and human plasma with good recoveries of 98.89% and 98.70%, respectively, without any interfering from matrix components. The corresponding regression equation, Y=0.756X+141.93, (r2=0.9994) for spiked plasma sample. Two level full factorial designs were used to study different experimental parameters that affect the reaction product and to get the optimum method conditions. The suggested method can be used in quality control lab as well as in pharmacokinetic studies of empagliflozin.