UPLC测定盐酸头孢甲肟原料药及注射剂的有关物质  

Determination of Related Substances of Cefmenoxime Hydrochloride Drug Substance and Injection by UPLC

作　　者：夏佳 席时东 XIA Jia;XI Shidong(Ningbo Institute for Drug Control,Ningbo 315048,China)

机构地区：[1]宁波市药品检验所

出　　处：《中国现代应用药学》2019年第22期2769-2772,共4页Chinese Journal of Modern Applied Pharmacy

基　　金：2018年国家药品抽样评价

摘　　要：目的建立UPLC测定盐酸头孢甲肟原料药及注射剂中有关物质的方法。方法采用Zorbax XDB C18柱(2.1 mm×100 mm,3μm),流动相A为水-冰醋酸-乙腈(85∶1.7∶15),流动相B为水-冰醋酸-乙腈(50∶1.7∶50),梯度洗脱,柱温30℃,流速为0.6mL·min^-1,检测波长为254nm。结果盐酸头孢甲肟与中间体、副产物完全分离。有关物质重复性RSD为2.5%,检测限为0.001~0.08μg·m L^-1。结论该方法快速、简便、灵敏度高、重复性好,优于现行标准方法。OBJECTIVE To establish UPLC for the determination of related substances of cefmenoxime hydrochloride drug substance and injection. METHODS The column was Zorbax XDB C18(2.1 mm×100 mm, 3μm). The mobile phase consisted of water-acetic acid-acetonitrile(85∶1.7∶15)(A) and water-acetic acid-acetonitrile(50∶1.7∶50)(B) with gradient program. The column temperature was 30 ℃. The flow rate was 0.6 m L·min^-1 and the detection wavelength was 254 nm. RESULTS Cefmenoxime hydrochloride could be completely separated from its intermediates and by-products. The RSD of related substances precision was 2.5%, the detection limit was 0.001-0.08 μg·m L^-1. CONCLUTION The method is rapid, simple, sensitive, reproducible and better than the current standard method.

关 键 词：超高效液相色谱法 盐酸头孢甲肟 有关物质 

分 类 号：R927.11[医药卫生—药学]