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C_(8)柱(Agilent ZORBAX SB C_(8)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.
The paper aims to establish a HPLC method to determine eleven kinds of impurities in tadalafil.Chromatographic column is C_(8)(Agilent ZORBAX SB C_(8)4.6 mm×250 mm,5μm);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 97.18%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.
作者
聂忠莉
曾胜莉
王晓玲
萧茂玲
黄金玉
NIE Zhongli;ZENG Shengli;WANG Xiaoling;XIAO Maoling;HUANG Jingyu(School of Food and Biological Engineering,Chengdu University,Chengdu 610106,China;Chengdu Climb Pharmaceutical Technology Co.,Ltd.,Chengdu 610041,China)
出处
《成都大学学报（自然科学版）》
2021年第4期351-354,共4页
Journal of Chengdu University（Natural Science Edition）
关键词
他达拉非
高效液相色谱法
杂质
测定
回收率
分离
tadalafil
high performance liqiud chromatographic method
impurities
determination
recovery rate
separation
