复方制剂阿莫西林和舒巴坦钠含量HPLC测定法

摘　要：目的　建立测定注射用阿莫西林和舒巴坦钠含量的方法。方法　采用高效液相色谱法，色谱柱为C18柱（10μm,4.6mm×250mm）;流动相：pH5.0氢氧化四丁基铵-乙腈（165∶35），检测波长为230nm。结果　精密度及稳定性均良好；阿莫西林及舒巴坦钠浓度分别在0.2758～0.8275mg·mL^-1和0.1517～0.4551mg·mL^-1范围内，峰面积与浓度（mg·mL^-1）呈良好的线性关系，相关系数均为0.9999，平均回收率为99.81%和100.3%,RSD分别为0.51%和0.67%。舒巴坦钠和阿莫西林之间，与其他杂质峰的分离度均符合要求。结论　本方法简便，重现性好，可同时测定舒巴坦钠和阿莫西林的含量。

关键词：阿莫西林；舒巴坦钠；高效液相色谱法

分类号：R917.1　文献标识码：A
文章编号：1001-2494(2001)03-0191-02

HPLC determination of amoxicillin and sulbactam sodium in compound injection

CHEN Ying-ying（Dalian Institute for Drug Control,Dalian 116021,China）　
CHEN Yun-le（Dalian Institute for Drug Control,Dalian 116021,China）　
Wang Hong-yan（Dalian Pfizer Pharmaceuticals Ltd.Dailian 116600,Chian）　

Abstract：OBJECTIVE　To develop a method for the determination of amoxicillin sulbactam sodium for injection.METHODS　An HPLC method was used with C18 column(10 μm,4.6 mm×250 mm);The mobile phase was a mixture of tetrabutylammonium hydroxide (adjusted to a pH of 5.0)-acetonitrile(165∶35) with the detection wavelength at 230 nm.RESULTES　The precision and stability were fine. The linear correlations of amoxicillin and sulbactam were observed over the concentrations 0.2758 to 0.8275 mg·mL^-1(r=0.9999) and 0.1517 to 0.4551 mg·mL^-1 (r=0.9999) respectively.The average recoveries of amoxicillin and sulbactam were (99.81±0.51)% and (100.3±0.67)% respectively. The resolution between the respective peaks of amoxicillin and sulbactam and the other peaks conformed to the requirements.CONCLUSION　The method was convenient and reproducible for the assay of amocillin and sulbactam simultaneously.

Keywords：amoxillin；sulbactam sodium;HPLC

参考文献：

［1］　　中华人民共和国卫生部部标准 WS1-(X-224)-98Z［S］.1998:84.
［2］　　USP.ⅩⅩⅣ［S］.2000：140.

收稿日期：2000年11月17日

出版日期：2001年3月1日