苯磺酸氨氯地平胶囊的高效液相色谱法测定

Determination of Amlodipine Besylate capsules by high performance liquid chromatography

目的：建立高效液相色谱法测定苯磺酸氨氯地平胶囊含量,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×150mm）;流动相：甲醇-0.03mol·L^-1磷酸二氢钾溶液（65：35）;检测波长：2 39nm。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9.952-99.520μg·ml^-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。杂质,可有效控制本品质量。

Objective：To control the quality of Amlodipine Besylate capsules by using high performance liquid chromatography to determine Amlodipine Besylate capsules. Methods.The chromatographic column of phenomenex ODS C18 （ 5μm, 4.6mm×4150mm） was used. The mobile phase consisted of methanol-0. 03mol· L^-1 KH2PO4 （65 ： 35 ）. The detection wavelength was at 239nm. Results ： Alfuzosin and the other components in the samples were completely separated. The relationship between response and the concentrations in the range of 9. 952-99. 520ug·mL^-1 was Linear with the correlation coefficient of 0. 9999. The average recovery was 99.09% ,100.4% and 101.2% ,respectively. RSD was 0. 12%. Conclusion. The method was specific,accurate and simple.