HPLC法测定替加氟注射液中的氟尿嘧啶等有关物质

HPLC determination of Fluorouracil and related substances in Tegafur Injection

目的:采用反相高效液相法测定替加氟注射液中的有关物质。方法:用十八烷基硅烷键合硅胶为填充剂;以甲醇-乙腈-水(10∶5∶85)为流动相;检测波长为271nm。结果:替加氟与氟尿嘧啶能完全分离,氟尿嘧啶检测限为3.3ng。结论:本法简便,专属性好,结果准确,可用于测定替加氟注射液的有关物质。

Objective：A HPLC method was established for the determination of Fluorouracil and related substances in Tegafur Injection.Method：The separation was performed on a ODS column（250 mm×4.6 mm,5 μm）.The mobile phase was composed of methanol-acetonitrile-water（10∶5∶85）,the detection wavelength was 271 nm.Result：Tegafur and Fluorouracil can be separated absolutely,and the limit of detection of Fluorouracil was 3.3 ng.Conclusion：The method is simple,rapid,accurate and can be used for the determination of related substances in Tegafur Injection.