Rp-HPLC法测定阿莫西林、克拉维酸钾的含量

Determination of contents of amoxicillin and clavulanate potassium by Rp-HPLC

目的 建立阿莫西林/克拉维酸钾中两种主要成分的含量测定.方法 采用液相色谱法,大连依利特Hypersil BDS C18柱（4.6×200 mm,5 μ m）为色谱柱;十二烷基硫酸钠溶液-乙腈（92∶8）为流动相;流速：1.0ml/min;柱温：25℃;检测波长：220nm;进样体积：10 μl.结果 克拉维酸在4.05～40.48μg范围内线性良好（r=0.9999）,平均回收率为99.7%（RSD=2.1%）;阿莫西林在1.15～11.53μg范围内线性良好（r=0.9999）,平均回收率为99.6%（RSD=0.7%）.结论 该方法准确度高,回收率良好,分离度较高,操作简单,可作为该制剂质量控制方法.

Objective To establish content determination method of amoxicillin and clavulanate potassium. Methods The parameters of detection was as followed： HPLC column： Hypersil BDS C18 （4.6× 200 mum, 5μm）; mobile phase： sodium dodecylsulfate solution - acetonitrile （92：8）; flow： 1.0ml/min;chromatographic temperature： 25C; detection wavelength： 220 nm; injection volume： 10 μ 1. ResultsThe linear range of clavulanate potassium was good at 4.05 - 40.48 μ g （ r = 0.9999 ） and the average recovery was 99.7% （RSD = 2.1%）; The linear range of amoxicillin was good at 1.15 - 11.53 μ g（ r = 0.9999 ）and the average recovery was 99.6% （RSD = 0.7%）. Conclusions This method is accurate and easy to use, with better recovery and higher separation. It can be used for quality control of the related preparations.