Improvement in the Methods for Content and Related Substances Determination of Glielazide Tablets(Ⅱ)

OBJECTIVE To improve the methods for content and related substances determination of Glielazide tablets(Ⅱ) METHODS The test solutions were made by acetonitrile instead of 40% acetonitrile aqueous solution. Chromatography was carried on a C₁₈ column(250 mm×4.6 mm, 5 μm) with the column temperature at 35 ℃, using water-acetonitrile-triethylamine- tirfluoroacetic acid(60∶40∶0.1∶0.1) as mobile phase at a flow rate of 1.5 mL·min^-1. The detective wavelength was set at 235 nm. The sample tray was at room temperature. RESULTS The test solutions of Glielazide tablets(Ⅱ) were stable in 24 h. The method had good linear relationships in 20-500 mg·L^-1(r=0.999 9), average recovery was 100.1%. The limits of quantitation and detection were 0.5 mg·L^-1 and 0.1 mg·L^-1, respectively. CONCLUSION The method improves the efficiency and reliability of test by resolving the problem of instability in the original standard.