文章编号：1004－5422(2021)04－0351－04

DOI:10.3969/j.issn.1004-5422.2021.04.003

高效液相色谱法测定他达拉非中11个杂质

聂忠莉¹，曾胜莉¹，王晓玲²，萧茂玲²，黄金玉² 

（1.成都大学  食品与生物工程学院，四川  成都  610106；2.成都克莱蒙医药科技有限公司，四川  成都  610041）

摘  要：建立高效液相色谱法测定他达拉非中的11个已知杂质.色谱柱为C₈柱(Agilent ZORBAX SB C₈ 4.6mm×250mm,5μm)；以0.1%三氟乙酸溶液为流动相A，以乙腈为流动相B，梯度洗脱；柱温为40℃，流速为1.0 mL/min,检测波长为285nm.结果显示，他达拉非中11种杂质分离较好，与主峰均能有效分离；11种杂质的平均回收率为97.18%～101.08%，ＲＳＤ为1.22%～5.97%.本法简便、准确、重复性好，可为他达拉非质量标准的制定提供参考.

关键词：他达拉非；高效液相色谱法；杂质；测定；回收率；分离

中图分类号：TQ460.72;O657.72        文献标识码：A

Determination of Eleven Kinds of Impurities in Tadalafil by HPLC

NIE Zhongli¹,ZENG Shengli¹,WANG Xiaoling²,XIAO Maoling²,HUANG Jingyu²

(1.School of Food and Biological Engineering,Chengdu University,Chengdu 610106,China;

2.Chengdu Climb Pharmaceutical Technology Co.,Ltd.,Chengdu 610041,China）

Abstract：The paper aims to establish  a HPLC method to determine eleven kinds of impurities in tadalafil.Chromatographic column is C₈( Agilent ZORBAX SB C₈ 4.6 mm×250 mm,5 μm );gradient elution is with 0.1% trifluoroacetic acid solution as mobile phase A and acetonitrile as mobile phase B;the column temperature is 40℃ and the flow velocity is 1.0 mL/min,the detection wavelength is 285 nm.The result show that the eleven kinds of impurities in tadalafil can be separated from the primary front effectively;The average recoveries of eleven impurities range from 97.318% to 101.08%,with RSD spanning from 1.22% to 5.97%.It can be concluded that this method is characterized by its succinctness exactness and good reproducibility,and offers refernces to the establishment of quality standard of tadaafil.

Key words：tadalafil;high performance liqiud chromatographic method;impurities;determination;recovery rate;separation