注射用盐酸头孢替安有关物质测定方法研究

Determination of related substances in cefotiam hydrochloride for injection

目的 建立测定注射用头孢替安有关物质的高效液相色谱法.方法 参照国家食品药品监督管理局发布的盐酸头孢替安碳酸钠混合粉标准,采用COSMOSIL C18（25cm×4.6mm,5μm）,以0.05mol/L磷酸盐缓冲液（pH值7.6～7.8-乙腈（88∶12）为流动相,流速为1.0mL/min,检测波长为254nm,柱温25℃.结果 采用所建立的有关物质检查方法,盐酸头孢替安的主峰及其杂质和各杂质之间能取得较好分离效果,最低检测限为5.028ng/mL.结论 该法简单、准确、灵敏度高,专属性强,可用于盐酸头孢替安有关物质检查.

Objective To establish high performance liquid chromatography （HPLC） methods for determination of related substances in cefotiam hydrochloride for injection. Methods According to the quality standard of cefotiam hydrochloride and sodium carbonate mixed powder announced by State Food and Drug Administration （SFDA）, the related substances were determined on a COSMOSIL C18 column （25cm×4.6mm, 5μm） with the mobile phase of 0.05mol/L phosphate buffer solution （pH7.6-7.8）-acetonitrile （88：12） at a flow rate of 1.0mL/min, detected at 254nm wavelength. The column temperature was 25 ℃. Results The peak and impurity can be well separated. The detection limit was 5.028ng/mL. Conclusion The method is simple, rapid, sensitive and specific, and can be used for determination of related substances in cefotiam hydrochloride for injection.