HPLC法测定头孢羟氨苄及其有关物质含量  

HPLC analysis of cefadroxil and its related substances

作　　者：钟长鸣 刘绪平 龚玮 王庆全 

机构地区：[1]江西省药品检验所,南昌330046

出　　处：《中国抗生素杂志》2004年第11期648-649,659,共3页Chinese Journal of Antibiotics

摘　　要：目的建立头孢羟氨苄有关物质的HPLC分析方法。方法采用ODS柱(Polaris250mm×4.6mm,5μm),以0.05mol/L磷酸盐缓冲液(用10mol/L氢氧化钾调节pH值为5.5)-乙腈(96∶4)为流动相,流速为0.7ml/min,检测波长为230nm。结果头孢羟氨苄、有关物质α-对羟基苯甘氨酸、7-氨基去乙酰氧基头孢烷酸(7-ADCA)的线性范围分别为0.125～1.0mg/ml(r=0.9997)、0.312～20μg/ml(r=0.9999)、0.312～20μg/ml(r=0.9999)。结论本方法可用于头孢羟氨苄及其有关物质含量的测定,方法准确、灵敏、简便。Objective To establish a method for determination of the related substances for cefadroxil. Method The column is Polaris C_~18 (250mm×0.46mm, 5μm). The mobile phase is composed of 0.05mol/L potassium dihydrogen phosphate solution (adjusted pH to 5.5 by 10mol/L potassium hydroxide solution) and acetontrile (96∶4); the flow rate is 0.7ml/min and the detection wavelength is 230nm. Results The standard curves (cefadroxil, α-p-hydroxyphenylglycine, 7-ADCA) are in the range of 0.125～1.0mg/ml (r=0.9997), 0.312μg/ml (r=0.9999), 0.312～20μg/ml (r=0.9999). Conclusion The method can be used on the analysis of cefadroxil and its related substances. The method is accurate, rapid and simple.

关 键 词：头孢羟氨苄 有关物质 色谱行为 

分 类 号：R927.2[医药卫生—药学]