高效液相色谱法测定乐卡地平中有关物质

HPLC determination of the related substances in lercanidipine

目的:建立乐卡地平中有关物质的测定方法。方法:反相高效液相色谱法,色谱柱为 Dismonsil^(TM)钻石 C_(18)(150 mm×4.6mm,5μm);流动相为乙腈-0.01 mol·L^(-1)醋酸铵溶液(含0.1%三二胺,pH=4.5,体积比65:35);流速1.0 mL·min^(-1);检测波长为215 nm。结果:乐卡地平质量浓度在2.5～40.0μg·mL^(-1)内,线性关系良好(r=0.9998)。结论:本法快速、灵敏、重现性好,可用于乐卡地平原料中有关物质的限度检查。

Objective：To develop a method so as to determine the related substances in lercanidipine. Methods： Dismonsil^TM C18 （150 mm ×4. 6 mm,5 μm）column was used,the mobile phase was composed of acetonitrile - 0. 1% triethylamine in 0. 01 mol · L^-1 ammonium acetate（65： 35） ,at a flow rate of 1 mL · min^-1 and the detect wavelength was 215 nm. Results：The linear calibration curves obtained in the concentration range of 2. 5 -40 μg · mL^- 1 （ r = 0. 9998）. Conclusion： This method is convenient, rapid, accurate, reproducible and suitable for the determination of related substances in Lercanidipine.