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 30ᵒC, 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.
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