HPLC法测定头孢替唑含量和有关物质

HPLC analysis of ceftezole and its related substances

目的建立头孢替唑HPLC含量测定和有关物质检查方法。方法使用YMc—PackODS—A等C18柱（150mm×4．6mm，5um），流动相为柠檬酸溶液．乙腈（90：10），检测波长254nm。结果头孢替唑在1．01-100．74ug／mL浓度范围内有良好的线性关系（n=9），y=25．2738x＋1．2344，相关系数r=1．0000，最低检出浓度为0．03ug／mL，最小定量浓度为0．1ug／mL。结论该方法为头孢替唑含量测定和有关物质检查提供了方便、灵敏、精确、可靠的方法。

Objective To establish an HPLC method for the determination of ceftezole and its related substances. Methods C18 columns （YMC-Pack ODS-A etc, 150mm×4.6mm, 5gm）were used. The mobile phase, citral solution：acetonitrile（90：10）. The detection wavelength was 254nm. Results The standard curve of ceftezole was linear in the range of 1.01-100.74ug/mL （r=l.0000）. The concentration limit was 0.03ug/mL, and the minimum detectable concentration was 0.1 ug/mL. Conclusion The method was convenient, sensitive, accurate and reliable for the determination of ceflezole and its related substances.