反相离子对色谱法测定2,5-二羟基苯磺酸盐及有关物质___

Objective:To establish an ion-pair-RP-HPLC method for the determination of dobesilates(including calcium dobesilate and ammonium dobesilate) and their related substances.Methods:The separation was performed on a Kromasil 100-5C₁₈ column(250 mm×4.6 mm,5 μm).The mobile phase was composed of acetonitrile-methyl alcohol-0.2% tetrabutyl ammonium bromide in 0.2% potassium dihydrogen phosphate solution(pH 3.10±0.05),(10∶25∶65).The detection was carried out with a UV detector and the detective wavelength was set at 260 nm.The flow rate was 10 mL·mL-1 and the column temperature was 30 ℃.Results:The calibration curves of calcium dobesilate and ammonium dobesilate were both linear between 20.0-500 μg·mL^-1;The correlation coefficient were 0.9999,0.9998,separately.The corresponding least detection limits were 1.44 ng and 1.64 ng,separately.The precisions were good(RSD=0.21%,0.23%).Conclusion:The method is credible and the results of the determination are accurate.