高效液相色谱法测定马来酸氨氯地平片的含量

HPLC determination of the contents of Amlodipine maleate in tablets

目的：建立高效液相色谱法测定马来酸氨氯地平片的含量。方法采用 Kromasil C18柱（4．6 mm ×250 mm，5μm）；以甲醇-0．05 mol·L －1乙酸铵溶液（70∶30）为流动相；检测波长365 nm；流速1．0 mL·min －1。结果马来酸氨氯地平在22．4～336．0 mg·L －1的线性范围内呈良好的线性关系，r ＝0．9999（n ＝6），平均回收率为99．4％，RSD ＝0．29％（n ＝9）。结论该方法简便、快速、准确、专属性好，适于马来酸氨氯地平片含量控制。

Objective To establish an HPLC method for the determination of the contents of Amlodipine maleate in tablets.Methods The separation was performed on a Kromasil C18 column （4.6 mm ×250 mm,5 μm）.The mobile phase was composed of methanol -0.05 mol·L -1 ammonium acetate （70∶30）at the flow rate of 1.0 mL·min -1 .The detection was carried out with a UV detector at 365 nm.Results The calibration curves were linear between 22.4 ~336.0 mg·L -1 （r =0.999 9,n =6）,and the average recovery was 99.4%,RSD =0.29%（n =9）.Conclusions The method is simple,rapid,accurate and suitable for the determination of amlodipine maleate tablets.