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目的:建立液-质联用法测定克拉维酸钾及其制剂的含量。方法:采用Restek C18色谱柱,流动相为5mmol.L-1醋酸铵溶液-乙腈(90∶10),流速0.7mL.min-1,柱温25℃;采用ESI离子源,多反应监测(MRM)扫描方式,负离子模式。结果:克拉维酸钾在10.33~1033μg.L-1范围内线性关系良好,相关系数为0.9989。阿莫西林克拉维酸钾(7∶1)分散片的平均回收率(n=9)为98.4%,RSD为0.97%;阿莫西林克拉维酸钾(4∶1)干混悬剂的平均回收率(n=9)为98.9%,RSD为1.1%;最低检测限为1.033μg.L-1。结论:本方法准确、快速,为克拉维酸钾及其制剂生产中的质量控制提供新的分析手段。
Objective: To establish a liquid chromatography - mass spectrometry method for the determination of potassium clavulanate and its preparations. Methods: Restek C18 column was used. The mobile phase was 5 mmol·L-1 ammonium acetate solution-acetonitrile (90:10), the flow rate was 0.7 mL.min-1 and the column temperature was 25 ℃. Scanning mode, negative ion mode. Results: Potassium clavulanate had a good linearity in the range of 10.33-1033μg.L-1 with a correlation coefficient of 0.9989. The mean recoveries (n = 9) for amoxicillin and potassium clavulanate tablets (n = 9) were 98.4% with a RSD of 0.97%. The average amoxicillin and potassium clavulanate (4: 1) The recovery (n = 9) was 98.9% with a RSD of 1.1% and the lowest detection limit was 1.033μg.L-1. Conclusion: This method is accurate and rapid, and provides a new analytical method for the quality control of potassium clavulanate and its preparations.