HPLC法同时测定注射用氨苄西林钠/氯唑西林钠的含量

Simultaneous content determination of ampicillin and cloxacillin in a pharmaceutical formulation for injection by HPLC

用阳离子交换柱的HPLC法同时测定注射用氨苄西林钠／氯唑西林钠中氨苄西林和氯唑西林的含量。色谱条件：采用Hypersil SCX柱，磷酸盐缓冲液（0.01mol／L磷酸氢二铵溶液，用磷酸调节pH值6．0）：乙腈（90：10）为流动相，检测波长225nm。氨苄西林和氯唑西林分别在45-134和44～131μg／ml范围内呈良好的线性关系，日内RSD分别为0．5％和0．6％，回收率分别为99．9％和100．0％，含量测定结果与国家药品标准方法所得结果相符。

A newly proposed HPLC method for simultaneous content determination of ampicillin and cloxacillin in a pharmaceutical formulation for injection was developed. The chromatographic condition was as follows, column： Hypersil SCX; mobile phase： phosphate buffer （0.01mol/L dibasic ammonium phosphate, adjusted to pH 6.0 with phosphoric acid） ： acetonitrile （90 ： 10）; detection wavelength： 225nm. The standard curves were linear within the range of 45-134 and 44-131μg/ml for ampicillin and cloxacillin respectively. The precisions in a day （RSD） were 0.5% and 0.6% respectively. The assay results complied with those obtained by using the national standard method.