HPLC法测定头孢羟氨苄原料及其制剂中有关物质的研究  

Determination of Related Substances in Cefadroxil and Preparations by HPLC

作　　者：刘云[1] 朱建平[1] 韩彬[1] 

机构地区：[1]河北省药品检验所,石家庄050011

出　　处：《中国药品标准》2011年第3期174-178,共5页Drug Standards of China

摘　　要：目的:建立新的头孢羟氨苄原料及制剂有关物质的HPLC分析方法。方法:采用十八烷基硅烷键合硅胶色谱柱,流动相A为0.02 mol.L-1磷酸二氢钾溶液(pH 5.0),流动相B为甲醇,采用梯度洗脱,流速为1.0 mL.min-1,检测波长为220 nm。结果:头孢羟氨苄与其降解产物在此条件下能够有效分离。结论:本方法简便、专属性强,可用于头孢羟氨苄原料及其制剂有关物质的检查,亦可以进行稳定性研究中降解产物的色谱检查。Objective： To establish a new method for determination of Cefadroxil and Preparations by HPLC. Method： The separation was achieved by using an ODS column with gradient eluent composed of 0.02 mol·L^-1potassium dihydrogen phosphate （ pH5.0 ） - methand. The flow rate was 1.0 mL ·min^ - 1. The UV detection wavelength was at 220 nm. Results： Cefadroxil and its related substances can be separated effectively by this method. Conclusion： This method is simple and reliable. It is suitable for determination of the related substances of Cefadroxil and Preparations and can also be used to analysis degradation products in the stability experiments.

关 键 词：高效液相色谱法 头孢羟氨苄 有关物质 

分 类 号：R978.11[医药卫生—药品]