Determination of Related Substance in Glycididazole Sodium by HPLC

OBJECTIVE To establish an HPLC method to determine the related-substance of glycididazole sodium. METHODS The assay was conducted on a CAPCELL ODS column (250 mm×4.6 mm, 5 μm) with 0.05 mol·L^-1 solution of ammonium acetate buffer (adjust to pH 7.1 with sodium hydroxide )-acetonitrile (80∶20) as mobile phase at the flow rate of 1.0 mL·min^-1, the detection wavelength was set at 316 nm, temperature was 35 ℃, and the injection volume was 20 μL. RESULTS Glycididazole sodium was completely separated from impurities. The linear concentration range of glycididazole sodium was 0.46-18.42 μg·mL^-1 with the correlation coefficient of 0.999 9. And the linear concentration range of metronidazole was 0.04-20.12 μg·mL^-1 with the correlation coefficient of 1.000 0, the average recovery was 98.81%(RSD=0.90%). CONCLUSION The method is sensitive, accurate and specific. It can be used to determine related-substance in glycididazole sodium.