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 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.

Analytical Quality by Design-Assisted HPLC Method for Quantification of Canagliflozin and Stability Studies

“…The IUPAC name of CAN is (2 S ,3 R ,4 R ,5 S ,6 R )-2-[3-[[5-(4-fluorophenyl)­thiophen-2-yl]­methyl]-4-methylphenyl]-6-(hydroxymethyl)­oxane-3,4,5-triol, and its molecular formula is C 24 H 25 FO 5 S; the structure is shown in Figure . The literature review reveals methods for the estimation of CAN in biofluids, humans, and rat plasma by liquid chromatography–mass spectrometry (LC/MS/MS) , and high-performance liquid chromatography (HPLC) − and the determination of related substances in CAN . Few methods using HPLC, − HPTLC, and UV , methods for the estimation of CAN in bulk or its pharmaceutical form have been documented.…”