HPLC法测定注射用头孢噻肟钠的有关物质  

An HPLC method for determination of related substances of cefotaxime sodium for injection

作　　者：赵霞[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国抗生素杂志》2008年第12期746-749,752,共5页Chinese Journal of Antibiotics

摘　　要：改进HPLC测定注射用头孢噻肟钠中有关物质的方法。在美国药典和欧洲药典(英国药典)方法的基础上,优化了两种不同流动相系统,用梯度洗脱对注射用头孢噻肟钠的有关物质进行了分离。结果样品中各成分的分离度及检出灵敏度完全满足有关物质限度的测定要求。改进后的RP-HPLC方法能更加真实有效的反映注射用头孢噻肟钠的有关物质含量,可有效控制产品的质量。To improve the method for determination of related substances of cefotaxime sodium for injection. On the basis of USP and EP （BP） methods, different mobile phase systems were optimized. Gradient elution was applied on the separation of eefotaxime sodium and its related substances. The resolution and sensitivity of related substances were acceptable. The simple and selective. It could be used to control th detection limit was 100ng. This method was found to be e quality of product effectively.

关 键 词：头孢噻肟钠 有关物质 高效液相色谱法 

分 类 号：R978.11[医药卫生—药品]