反相高效液相色谱法测定洛索洛芬钠的含量及其有关物质

RP-HPLC determination of loxoprofen sodium and its related substances

目的:建立洛索洛芬钠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Kromasil-C_(18)色谱柱(250mm×4.6mm,5μm),以乙腈-水(40∶60,10%磷酸溶液调pH=3.5)为流动相,流速为1.0mL·min^(-1),检测波长为222nm。结果:建立的色谱方法使有关物质与主药分离良好,洛索洛芬钠在5.096～45.864μg·mL^(-1)范围内,浓度与峰面积线性关系良好。结论:本法简便、准确,可用于洛索洛芬钠的含量测定及其有关物质的测定。

Objective:To establish a method for determination of loxoprofen sodium and its re- lated substances.Methods:The chromatographic conditions adopted were:Kromasil-C_(18) column(250mm×4.6mm,5μm),a mobile phase of acetonitrile-H_2O (40∶60,pH 3.5,adjusted by 10%H_3PO_4 solution),a flow rate of 1.0mL·min^(-1),and a detection wavelength of 222nm.Results:Loxo-profen sodium and its related substances can be completely separated by the method with a liner rangeof 5.096～45.864μg·mL^(-1).Conclusion:A simple and accurate method is established for determina-tion of loxoprofen sodium and its related substances.