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目的建立简便、快速分析克拉维酸钾及其制剂的毛细管区带电泳方法。方法采用非涂层石英毛细管柱,有效长度50 cm;运行缓冲溶液,20 mmol/L磷酸盐缓冲液(pH 6.0);工作电压25 kV;进样电压20 kV,进样时间5 s:柱温20℃;检测波长21 4 nm。结果克拉维酸钾在52.08～312.5 mg/L范围内线性关系良好,相关系数为0.999 6。阿莫西林克拉维酸钾(7:1)分散片的平均回收率(n=9)为99.2%,相对标准差(relative standarddeviation,RSD)为0.77%;阿莫西林克拉维酸钾(4:1)干混悬剂的平均回收率(n=9)为99.4%,RSD为1.0%;最低检测限为1.953 mg/L。结论本方法简便、准确、快速,为克拉维酸钾及其制剂生产中的质量控制提供了一种新的分析手段。
Objective To establish a simple and rapid method for the determination of potassium clavulanate and its preparations by capillary zone electrophoresis. Methods The uncoated silica capillary column was used with an effective length of 50 cm. The running buffer solution was 20 mmol / L phosphate buffer (pH 6.0). The working voltage was 25 kV. The injection voltage was 20 kV and the injection time was 5 s. 20 ℃; detection wavelength of 21 4 nm. Results Potassium clavulanate had a good linearity in the range of 52.08-312.5 mg / L with a correlation coefficient of 0.999 6. The average recoveries (n = 9) for amoxicillin and potassium clavulanate (7: 1) dispersions were 99.2% with relative standard deviations (RSDs) of 0.77% and amoxicillin potassium clavulanate (4: 1) The average recovery (n = 9) of dry suspensions was 99.4% with a RSD of 1.0% and the lowest detection limit was 1.953 mg / L. Conclusion The method is simple, accurate and rapid and provides a new analytical method for the quality control of potassium clavulanate and its preparations.