苯磺酸氨氯地平片的HPLC测定

HPLC determination of amlodipine besylate tablets

目的建立高效液相色谱法测定苯磺酸氨氯地平片含量，为质量控制提供有效的分析手段。方法色谱柱：Phenomenex ODS C18（5μm，4．6mm×150ram）；流动相：甲醇-0．03mol·L-1磷酸二氢钾溶液（65：35）；检测波长：239nm。结果制剂中辅料和有关物质对主药无干扰，苯磺酸氨氯地平在浓度9．952—99．520mg·L^-1范围内线性关系良好，相关系数r=0．9999（n=6）；平均回收率分别为99．09％、100．4％、101．2％，RSD为0．12％。结论本法专属性好，准确，简便。

Aim To develop HPLC method for the determination of amlodipine besylate tablets for quality control of amlodipine besylate tablets. Methods The chromatographic column of phenomenex ODS C28 （ 5 μm,4.6 mm × 150 mm）was used. The mobile phase consisted of methanol-0.03 mol·L^-1 KH2 pQ （ 65：35 ）. The detection wavelength was at 239 nm. Results Alfuzosin and the other components in the samples were separated completely. The relationship between response and the concentration on the range of 9. 952 - 99.520 mg ·L^-1 was linear with the correlation coefficient of 0. 9999. The average recovery were 99.09 % ,100.4 % and 101.2 % ,RSD =0.12 %. Conclusion The method was specific, accurate and simple.