【摘要】 目的 :建立马来酸氨氯地平片中马来酸氨氯地平及杂质的测定方法。方法 :采用高效液相色谱法 ,色谱柱 :Shim PackCLC ODS(15 0mm× 6 .0mm)不锈钢柱 ,流动相 :甲醇 0 .0 3mol·L-1磷酸二氢钾溶液 (72∶2 8) ,检测波长 2 37nm ,含量测定采用外标法 ,杂质检查采用面积归一化法。结果 :在优化的色谱条件下 ,氨氯地平、马来酸及杂质间均能完全分离 ,片剂辅料不干扰测定 ,马来酸氨氯地平线性范围 1.0～ 12 0 .0 μg·mL-1,最低检测限 0 .2 μg·mL-1,含量测定的回收率 98.73%～ 10 0 .9% ,RSD <1.5 %。结论 :该法专属性强 ,操作方便 ,结果准确 ,重现性好。更多还原

【Abstract】 Objective:To establish a HPLC method for the determination of amlodipine maleate and impurities in amlodipine maleate tablet.Methods:Reversed phase chromatographic separation was carried out on a shim pack CLC ODS column(150mm×6.0mm) equilibrated with an eluent mixture constituted by CH 3OH 0.03 mol·L -1 KH 2PO 4 solution (72∶28).The ultraviolet detection was at 237nm.The quantitative determination of amlodipine maleate was performed with external standard method and the impurity limitation was performed with area normalization method.Results:Complete separation was achieved among amlodipine, maleic acid and impurities under optimum conditions.No interference from tablet excipient was found.The standard curve was linear over the concentration range of 1.0 to 120.0μg·mL -1 for amlodipine maleate and the limit of quantification was 0.2μg·mL -1 .The recoveries of amlodipine maleate were in the range of 98.73% to 100.9% with RSD less than 1.5%.Conclusion:The proposed method is simple,accurate,reproducible and highly selective. [更多还原