HPLC Determination of Glucono-δ-Lactone in Canagliflozin

A method for determination of Glucono-δ-Lactone (GDL) in Canagliflozin was proposed by HPLC coupled with charged aerosol detection (HPLC-CAD). The optimized chromatographic conditions were as follows:① Thermo Hypersil Gold Aq column (250 mm×4.6 mm, 5 μm) was used as stationary phase; ② the mobile phase was a mixture of acetonitrile-water (9+1) solution with a flow rate of 0.5 mL·min^-1; ③ column temperature was 30 ℃; ④ the injection volume was 10 μL; ⑤ the nebulization temperature of CAD was set at 50 ℃, and pressure of carrier gas was 427.5 kPa. Under above chromatographic conditions, linearity range for GDL in mass concentration found was 1.05-22.5 mg·L^-1, and the detection limit (3S/N) found was 0.32 ng. Test for recovery was made by standard addition method at 3 concentration levels, giving results in the range of 96.2%-103%. The sample solution and reference solution were stable for 12 h at room temperature, and RSDs (n=7) found were 1.8% and 1.3%, respectively.