注射用盐酸头孢甲肟含量测定及有关物质检查方法的研究

Determination of cefmenoxime hydrochloride for injection and it′s related substances by HPLC

目的用HPLC法测定注射用盐酸头孢甲肟中头孢甲肟的含量及有关物质。方法采用ODS C18（200mm×4．6mm，5pro）色谱柱，流动相采用水：冰乙酸：乙腈（850：17：150），流速1．0ml／min，检测波长254nm。结果溶液浓度在0．06～500μg／ml范围内线性良好，r=0．9997（n=12），方法平均回收率为99．87％，RSD为0．36％（n=9）。盐酸头孢甲肟杂质数目为14至15个，总量为1．00～1．58％。结论本法简便、准确、灵敏度高，可用于注射用盐酸头孢甲肟的含量和有关物质检查，亦可以进行稳定性研究中降解产物的色谱检查。

Objective To develop a method for the determination of cefmenoxime hydrochloride for injection and it＇s related substances by HPLC. Method Samples were analyzed on an ODS C18 column with mobile phase of water ： glacial acetic acid ： acetonitrile （850 ： 17 ： 150） at flow rate 1.0ml/min and detection wavelength of 254nm. Result The standard curves were linear in the range of 0.06 ～ 500μg/ml （r =0. 9997）. The average recovery was 99.87% （RSD= 0. 36 % ）. The number of related substances in cefmenoxime hydrochloride is 14～15 and the total amount is 1.00%～1.58%. Conclusion The method is simple, accurate and suitable for the determination of cefmenoxime hydrochloride and it＇s related substances. It can also be used to analyzed degradation products in the stability experiments.