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

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，3 μm），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0.6 mL·min^-1，检测波长为254 nm。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0.001~0.08 μg·mL^-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。

Abstract: 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 mL·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·mL^-1. CONCLUTION The method is rapid, simple, sensitive, reproducible and better than the current standard method.