梯度洗脱HPLC法测定盐酸头孢甲肟原料药及注射粉末的有关物质  

Gradient HPLC determination of related substances of cefmenoxime hydrochloride drug substance and its sterillized powder for injection

作　　者：阮丹[1] 王红波[1] 王建[2] 

机构地区：[1]浙江工业大学,杭州310004 [2]浙江省食品药品检验所,杭州310004

出　　处：《中国抗生素杂志》2012年第11期843-846,I0004,共5页Chinese Journal of Antibiotics

基　　金：国家药典委员会国家药品标准提高研究项目(编号国药典综发[2010]210号)

摘　　要：目的建立梯度洗脱HPLC法,测定盐酸头孢甲肟原料药及其注射粉末的有关物质。方法采用AlltimaC18(250×4.6mm,5μm)柱,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),流速为1.0mL/min,线性梯度洗脱,检测波长为254nm。结果盐酸头孢甲肟与4种中间体、副产物完全分离。重复性RSD为2.9%,检测限为0.01～0.1μg/mL。结论方法简便、灵敏、重复性好,可用于本品的质量控制。Objective To develop gradient HPLC method for the determination of related substances of cefmenoxime hydroehloride drug substance and its sterillized powder for injection. Methods The column was Alltima C18（250×4.6mm, 5μm）. The mobile phase consisted of water-acetic acid acetonitrile（85：l.7：15）（A） and water-acetic acid-acetonitrile（50：1.7：50）（B） with gradient program. The flow rate was 1.0mL/min and the detection wavelength was 254nm. Results Good separation of cefmenoxime hydrochloride and four intermediates could be achieved. The RSD of precision was 2.9%. The detection limit was 0.01-0.1 μg/mL. Conclusion The method is simple, sensitive and reproducible, and can be used for quality control of cefmenoxime hvdrochloride.

关 键 词：盐酸头孢甲肟 有关物质 高效液相色谱法 梯度洗脱 

分 类 号：R978.1[医药卫生—药品]