反相高效液相色谱法测定二氟尼柳的含量及其有关物质

RP-HPLC determination of diflunisal and its related substances

目的:建立二氟尼柳的含量及其有关物质的反相高效液相色谱测定方法。方法:采用YWG C_(18)色谱柱(200mm×4.6mm,5μm),以水-甲醇-乙腈-冰醋酸(55:23:30:2)为流动相,流速为1.5mL·min^(-1),检测波长为254nm。结果:建立的色谱方法使有关物质与主药分离良好,二氟尼柳在40～160μg·mL^(-1)范围内,浓度与峰面积线性关系良好,平均回收率99.87％。结论:本法简便、准确,可用于二氟尼柳的含量及其有关物质的测定。

Objective:To establish a method for determination of diflunisal and its related substances. Methods:The chromatographic conditions adopted were: YWG C18 column (200mm×4. 6mm, 5μm) ,a mobile phase of H2O-CH3OH-acetonitrile-glacial acetic acid (55:23:30:2) ,a flow rate of 1.5 mL·min-1 ,and a detection wavelength of 254nm. Results: Diflunisal and its related substances can be completely separated by the method with a liner range of 40 - 160μg·mL-1 and an average recovery of 99.87%. Conclusion: A simple and accurate method is established for determination of diflunisal and its related substances.