江志华,黄奇建,康丽红
JIANG Zhihua,HUANG Qijian,KANG Lihong

• 1:广东恒健制药有限公司

摘要(Abstract)：

目的建立用HPLC法检测富马酸酮替芬滴眼液中的有关物质。方法用十八烷基硅烷键合硅胶为填充剂;以水-三乙胺(500∶0.175)为流动相A,以甲醇-三乙胺(500∶0.175)为流动相B;检测波长为297 nm,柱温为40℃;进样量:20μL。结果该色谱系统能完全分离经光照、高温破坏所产生的杂质峰、辅料峰及主峰。富马酸酮替芬的检测限为2 ng,本方法可检测到0.02%的杂质。结论本法专属性强,操作简便,灵敏,可用于富马酸酮替芬滴眼液中的有关物质检查。
OBJECTIVE To establish a method to test related substances in Ketotifen Fumarate eye drops by HPLC. METHODS A column packed with octadecylsilanized silica gel was used for liquid chromatography. The mixture of water-trithylamine( 500 ∶0. 175) was used as the mobile phase A,and the mixture of methanol-trithylamine( 500∶ 0. 175) was used as the mobile phase B. The detection wavelength was 297 nm,the column temperature was 40 ℃,and the sample size was 20 μL. RESULTS The ketotifen main peak was effectively separated from adjacent impurity peaks. The detection limits for Ketotifen Fumarate was 2 ng. CONCLUSION The method was simple,sensitive,and can be used for quality control of this preparation.

关键词(KeyWords)： HPLC法;富马酸酮替芬滴眼液;有关物质
HPLC;Ketotifen Fumarate eye drops;related substances

Abstract:

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基金项目(Foundation):

作者(Author): 江志华,黄奇建,康丽红
JIANG Zhihua,HUANG Qijian,KANG Lihong

参考文献(References)：

• [1]国家药典委员会.中华人民共和国药典[S].二部.北京:中国医药科技出版社,2010:1058
• [2]British pharmacopoeiacommission Ketotifen Fumarate British pharmacopoeia,2009.