RP-HPLC法测定苯磺酸左旋氨氯地平有关物质

Determination of Related Substances in Levamlodipine Besylate by RP-HPLC

目的:建立反相高效液相色谱法测定苯磺酸左旋氨氯地平有关物质。方法:参照其国家标准中色谱方法,确定更合适的有关物质测定方法。并以此色谱方法按中国药典要求进行方法性验证。采用HPLC法,使用C18柱(250 mm×4.6 mm,5μm),以甲醇-0.03 mol/L磷酸二氢钾溶液(60∶40)为流动相。结果:该方法的专属性、耐用性等均较好,检测限为0.01 ng。结论:该方法适用于苯磺酸左旋氨氯地平的有关物质的测定。

Objective： To establish a method for the test of related substances in levamlodipine besylate. Methods： The different ratios between methanol and 0,03 mol/L KH2PO4 in mobile phase were adjusted to test the related substances more effectively. And the HPLC method based on the selected chromatographic system was validated according to the requirement in Chinese Pharmacopoeia. The related substances were determined by HPLC with C18 cohurm（250 mm× 4.6 mm,5μm）, and with methanol-0.03 mol/L KH2PO4 （60：40） as mobile phase. Results： The robustness and durability of the method were preferably well, and LOD was 0.01 ng. Conclusion： The method was applicable for detecting related substances in levamlodipine besylate.