RP-HPLC同时测定阿莫西林和甲硝唑含量

Study on the determination of amoxicillin and metronidazole by RP-HPLC

目的建立一种同时测定阿莫西林和甲硝唑含量的简单、快速和灵敏的反应高效液相色谱方法,为制剂的质量控制提供手段。方法采用LC-10A(岛津)高效液相色谱仪,以Hypersil ODS柱(150mm×4.6mm,5μm)为分析柱;流动相为10mmol.L-1;进样量为20μL;检测波长为254nm。结果阿莫西林和甲硝唑色谱峰分离良好,辅料无干扰,线性关系良好;阿莫西林和甲硝唑的最低检测浓度分别为0.02μg.mL-1和0.05μg.mL-1,平均方法回收率分别为99.10±1.3%和100.1±1.0%,日内、日间RSD均小于1.7%。结论本方法准确灵敏、操作简便、快速、专属性强,适用于制剂中阿莫西林和甲硝唑含量的同时测定。

OBJECTIVE To develop a RP-HPLC method to determine the content of amoxicillin and metronidazole Simaltaneously in vitro. METHODS A reversed phase C18 column （ 150 × 4.6mm 1. D. ,5 μm） was used for the determination amoxicillin and metronidazole with a mobile phase composed of 10mm phosphate buffer solution （pH4.0）-methanol（95：5, v/v）at a flow rate of 1.0 ml · min^-1. The detector was operated at the 254nm wavelength. RESULTS The chromatography was good and do not interfered by other components. The method recoveries were 99.10 ± 1.3% for amoxicillin and 100.1 ± 1.0% for metronidazole. The limits of detection were 0. 02μg · mL^-1 and 0. 05μg · mL^-1. The intra-and inter-day imprecision （C. V. ）did not exceed 1.7% CONCLUSION The method is accurate, sensitive and convenient, and is suitable for the determination of amoxicillin and metronidazole simultaneously.