HPLC法测定阿莫西林克拉维酸钾干混悬剂中克拉维酸钾的含量

目的建立高效液相色谱法测定阿莫西林克拉维酸钾干混悬剂(4︰1)中克拉维酸钾的含量。方法采用AgilentEclipseC18柱(150mm×4.6mm/5μm),Agilent1200s高效液相色谱仪,流动相:以0.78%的磷酸二氢钠水溶液(pH=4.4)-甲醇(95︰5)为流动相,流速:1.0mL/min,柱温30℃,检测波长:220nm;自动进样,体积为20μL;分析时间11min,外标法定量。结果克拉维酸在0.0501～0.1754mg/mL浓度范围内线性关系良好,平均回收率(n=9)为98.97%,RSD为0.50%。克拉维酸钾(以克拉维酸计)为其标示量的90.0%～110.0%。结论该测定方法简便、准确、可靠,灵敏度高,可作为质量控制方法。

Determination of clavulanate potassium in the amoxicillin and clavulanate potassium dry suspension by HPLC

Objective To establish a high performance liquid chromatography method for simultaneous determination of clavulanate potassium in amoxicillin and clavulanate potassium dry suspension.Methods The analysis was carried out on a Agilent Eclipse C18 column(150 mm×4.6 mm/5 μm),using Agilent1200s of HPLC with the mobile phase of 0.78% sodium dihydrogen phosphate buffer solution(pH 4.4)-methanol(95 ︰ 5),adopting quantitative by external standards.The flow rate was 1.0 mL/min,and the column temperature was 30℃ and the detective wave was 220 nm with injection volume of 20 μL and analyses time of 11 minutes.Results The linear range of clavulanate was 0.050 1-0.175 4 mg /mL(r=0.999 9).The average recovery was 98.97%,and the RSD(n=9) was 0.50%.Clavulanate potassium(calculated on the basis of clavulanic acid) was 90.0%-110.0% of the labelled amount.Conclusion The method is simple,accurate,sensitive and applicable for quality control of this product.