HPLC法测定注射用盐酸吡硫醇中有关物质的含量

Determination of related substances in pyritinol hydrochloride for injection by HPLC

目的建立注射用盐酸吡硫醇中有关物质的HPLC测定方法。方法采用十八烷基硅烷键合硅胶为填充剂(150 mm×4.6 mm,5μm),以乙腈-水-三乙胺(20∶80∶0.1)(以磷酸调pH至5.0)为流动相,检测波长295 nm。结果在选定的色谱条件下,20 min内注射用盐酸吡硫醇中有关物质与盐酸吡硫醇能较好的分离。结论本法简便,专属性强,适用于注射用盐酸吡硫醇中有关物质的检查。

Aim To determine the related substances in pyritinol hydrochloride for injection by HPLC. Methods A hypersil Conscolumn （150mm×4.6mm,5μm） was used with the mobile phase of acetonitrile-H2 O- triethylamine（20： 80：0.1 ） at the detection wavelength of 295 nm. Results Under the optimal conditions, a good separation was achieved for pyritinol hydrochloride and its related substances. Conclusion The simple and selective method was successfully used to determine the related substances of pyritinol hydrochloride.