高效液相色谱法测定苯磺酸左旋氨氯地平片的含量及有关物质

Determination of levamlodipine besylate and its relevant substances in levamlodipine besylate tablets by HPLC

目的建立高效液相色谱法测定苯磺酸左旋氨氯地平片的含量及有关物质。方法采用AgilentHC-C18色谱柱(4.6mm×250mm,5μm),流动相:甲醇-0.03mol.L-1磷酸二氢钾溶液(75:25),流速:1.0mL.min-1,检测波长:238nm,柱温:30℃,进样量:10μL。结果苯磺酸左旋氨氯地平在10.68～53.40μg.mL-1与峰面积呈良好线性关系(r=0.9996),平均回收率(n=9)为99.9%;检测限为2.40ng(S/N=3)。结论该方法简便、结果准确,适于苯磺酸左旋氨氯地平片的质量控制。

Objective To establish an HPLC method for the content determination and its relevant substances of levamlodipine besylate tablets.Methods HPLC was conducted on an Agilent HC-C18 4.6 mm×250 mm,5 μm）column with methanol-0.03 mol·L-1potassium dihydrogen phosphate solution（75：25） as the mobile phase at 1.0 mL·min-1.The detective wavelength was 238 nm,the injection volume was 10 μL,and the column temperature was 30 ℃.Results The linear range of levamlodipine besylate was 10.68-53.40 μg·mL-1 （r=0.999 6）,and the av-erage recovery（n=9）was 99.9%.The detection limit was 2.40 ng（S/N=3）.Conclusion The method is simple,accurate,and can be used for the quality control of levamlodipine besylate tablets.