河北工业科技2018，Vol.35Issue(4)：299-304,6.DOI:10.7535/hbgykj.2018yx04013
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
摘要
Abstract
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 amoxicil-lin and Clavulanate potassium tablets.RP-HPLC method is established on a Ultimate AQ-C18 column (4.6 mm×250 mm,5 μm)with 0.05 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 rela-tion between control solution (0.0500 ～0.5001 mg/mL)and peak area is good (r =0.9998),the average recoveries (n = 9)is 100.14％ and RSD is 0.24％.The linear relation between amoxicillin control solution (0.1000～1.0001 mg/mL)and peak area is good(r =0.9999),the average recoveries (n =9)is 100.45％ and RSD is 0.17％.Compared with the method of ChP,the new determina-tion 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.关键词
色谱分析/阿莫西林/克拉维酸钾/含量测定/高效液相色谱法Key words
chromatographic analysis/Amoxicillin/Clavulanate potassium/determination of concentration/HPLC分类
医药卫生引用本文复制引用
张静岩,张炜,任风芝,张雪霞,王海燕,孟令茹..阿莫西林克拉维酸钾片含量测定方法的改进[J].河北工业科技,2018,35(4):299-304,6.基金项目
河北省科技条件建设项目 (169676404G) （169676404G）
中央引导地方科技创新专项资金 （）
