盐酸头孢吡肟的HPLC测定及有关物质检测  

Simultaneous determination of cefepime HCI and its related substances by RP-HPLC

作　　者：闫小燕[1] 胡欣[1] 曹国颖[1] 何笑荣[1] 

机构地区：[1]卫生部北京医院药剂科,北京100730

出　　处：《中国新药杂志》2004年第1期47-49,共3页Chinese Journal of New Drugs

摘　　要：目的:建立盐酸头孢吡肟的HPLC测定及有关物质检测方法。方法:采用C18柱(250mm×4 6mm,5μm),流动相为乙腈-0.015mol·L-1戊烷磺酸钠(9:91,pH 4.0),检测波长为258nm,流速0.8mL·min-1。结果:盐酸头孢吡肟在9.4-1 202μg·mL-1浓度范围内,峰面积与浓度呈良好线性关系(r=1.000 0),平均回收率为(100.87±1.69)％,最低检测限为3.55ng。结论:本法简便、专属和重现性好,可用于测定盐酸头孢吡肟含量及有关物质。Objective: To establish a method for simultaneous determination of cefepime HCl and its related substances. Methods: Chromatographic conditions selected: a C18 column (250mm×4. 6mm,5μm) ;a mobile phase consisted of acetonitrile: 0.015mol· L-1 sodium pentane-sulfonate = 9: 91 (pH 4.0) ;a detection wavelength of 258nm and a flow rate of 0.8mL·min-1. Results: The liner range,average recovery and lowest detection limit for cefepime HCl obtained were 9.4-1 202 μg· mL-1(r=1.000 0), (100. 87±1. 69) % and 3. 55ng respectively. The peak resolution of the method conforms to requirement. Conclusion: A simple,specific,and reproducible method is established suitable for simultaneous determination of cefepime HC1 and its related substances.

关 键 词：盐酸头孢吡肟 高效液相色谱法 有关物质 

分 类 号：R927.2[医药卫生—药学]