阿莫西林克拉维酸钾片含量测定方法的改进

Improvement of the determination method for the Amoxicillin and Clavulanate potassium tablets

为解决实际应用中克拉维酸钾峰与后相邻杂质的分离度达不到要求的问题,建立了一种同时测定阿莫西林克拉维酸钾片中阿莫西林和克拉维酸钾含量的新方法,采用反相高效液相色谱法(RP-HPLC),Ultimate AQ-C_(18)色谱柱(4.6mm×250 mm,5μm),以pH值为4.4的0.05 mol/L磷酸二氢钠缓冲液为流动相,柱温为35℃,流速为1.0mL/min,检测波长为220nm。结果表明:阿莫西林和克拉维酸钾两主峰与相邻杂质得到完全基线分离,分离度大于1.5;克拉维酸钾对照品溶液质量浓度为0.050 0~0.500 1mg/mL时与峰面积的线性关系良好(r=0.999 8),平均回收率(n=9)为100.14%,RSD值为0.24%;阿莫西林对照品溶液质量浓度为0.100 0~1.000 1mg/mL时与峰面积的线性关系良好(r=0.999 9),平均回收率(n=9)为100.45%,RSD值为0.17%。与原有的《中华人民共和国药典》方法相比,新的阿莫西林克拉维酸钾片含量测定方法专属性好,准确度高,操作简便快捷,结果可靠,可作为一种质量控制方法。

In order to solve the problem that the separation degree between the Clavulanate potassium peak and the subsequent adjacent impurity can not meet the requirement in practical application,a new determination method is established for the the amoxicillin and Clavulanate potassium tablets.RP-HPLC method is established on a Ultimate AQ-C18 column（4.6 mm×250 mm,5μm）with0.05 mol/L phosphate buffer solution（0.05 mol/L duodenum hydrogen phosphate,adjusted pH to 4.4）as a mobile phase.The column temperature is 35 ℃,the flow rate is 1.0 mL/min,and the detection wave length is 220 nm.The result shows that the adjacent peaks are Completely separated from the main peaks of Clavulanate potassium and Amoxicillin,the resolution is over 1.5,and the linear relation between control solution（0.050 00.500 1 mg/mL）and peak area is good（r=0.999 8）,the average recoveries（n=9）is100.14% and RSD is 0.24%.The linear relation between amoxicillin control solution（0.100 01.000 1 mg/mL）and peak area is good（r=0.999 9）,the average recoveries（n=9）is 100.45%and RSD is 0.17%.Compared with the method of ChP,the new determination method for Amoxicillin and Clavulanate potassium tablets has the advantages of betterspecificity with more accurate result,and it is simple,quick,reliable,and applicable for quality control.