A Novel and Rapid RP-HPLC Quantitative Method for the estimation of Canagliflozin in Human Plasma

Abstract

A simple, precise and accurate method was developed for the quantitative estimation of Canagliflozin in human plasma using Dapagliflozin as internal standard by Reverse Phase-High Performance Liquid Chromatographic technique. Chromatographic conditions were of stationary phase Phenomenex Luna C18 (2) (150 x 4.6 mm, 5m), Mobile phase 0.01 N Potassium dihydrogen Phosphate buffer pH (3.5 ± 0.05) :  acetonitrile in the ratio of 45:55 and flow rate  at 1.0 ml/min, detection wave length was UV 222 nm, column oven temperature was maintained at 30^oC, and sample injection volume of 10 µL. Retention time of Canagliflozin was found to be about 8.7 min. Coefficient of Variation for Canagliflozin peak was 3.15 %, % recovery was 94.58 %.  The linearity of method was studied from 0.06 µg/ml to 2.4 µg/ml (R2  = 0.999).   The Signal to Noise ratio of lower limit of quantification (0.06 µg/ml) was found to be 50. The proposed bio-analytical method was validated by following ICH guidelines.