赵云丽,潘强,陈明明,于治国
ZHAO Yun-li1; PAN Qiang2; CHEN Ming-ming3; YU Zhi-guo1 (1.School of Pharmacy;

• 1:沈阳药科大学药学院
• 2:辽宁省药品检验所
• 3:沈阳军区药材仓库
• 4:沈阳药科大学药学院 辽宁沈阳110016

摘要(Abstract)：

目的建立利拉萘酯及其有关物质的高效液相色谱测定法。方法采用KromasilC8柱(15 0mm× 4 6mm ,5 μm) ,乙腈 水 四氢呋喃 (V∶V∶V =5 5∶4 0∶5 )为流动相 ,紫外检测波长为2 86nm。结果利拉萘酯峰与有关物质获得基线分离 ,利拉萘酯线性范围为 0 4～ 2 μg,有关物质检测限 (S/N =3)为 1ng(相当于利拉萘酯量的 0 0 1% )。结论本法简便、专属、灵敏 ,具有良好的重现性 ,适用于利拉萘酯及其制剂的质量控制。
Objective To develop a reversed-phase high-performance liquid chromatographic method for determination of liranaftate and its related substances.Method The liranaftate and its related substances were separated on a Kromasil C 8 column( 150 mm× 4.6 mm, 5 μm).The mobile phase consisted of acetonitrile-H 2O-THF (V∶V∶V=55∶40∶5).The UV detector was set at 286 nm.Result The liranaftate and its related substances can be separated on the baseline and determined accurately.The calibration curve is linear from 0.4 to 2 μg for liranaftate.The limit of detection is 1ng,equivalent to 0.01% of liranaftate,for the related substances.Conclusion The method is simple,selective,sensitive with good repeatability,and can be used in the quality control of liranaftate.

关键词(KeyWords)： 利拉萘酯;有关物质;反相高效液相色谱法
liranaftate; related substances; RP-HPLC

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 赵云丽,潘强,陈明明,于治国
ZHAO Yun-li1; PAN Qiang2; CHEN Ming-ming3; YU Zhi-guo1 (1.School of Pharmacy;

参考文献(References)：

• [1]钟倩.角鲨烯环氧化酶抑制剂抗真菌药利拉萘酯[J].国外医药合成药、生化药、制剂分册,2001,22(3):190.
• [2]HiroshiA ,YoshimitsuT ,KenjiT ,etal.Physico chemi calpropertiesandstabilityofLiranaftate[J].IyakuhinKenkyu,1992,23(5):558-572.