GC法直接测定药用辅料油酸乙酯的脂肪酸组成  

Direct determination of fatty acids composition in pharmaceutical excipient of ethyl oleate by GC

作　　者：方欣欣[1] 章娟[2] 陈蕾[3] 邱娟[2] 邵泓[1] 郑璐侠[1] FANG Xinxin;ZHANG Juan;CHEN Lei;QIU Juan;SHAO Hong;ZHENG Luxia**(Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Guangzhou Institute for Drug Control,Guangzhou 510160,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]上海市食品药品检验所,上海201203 [2]广州市药品检验所,广州510160 [3]国家药典委员会,北京100061

出　　处：《中国药品标准》2021年第5期450-453,共4页Drug Standards of China

基　　金：国家药典委员会药品标准制修订研究课题:2019Y020。

摘　　要：目的:建立气相色谱法直接测定药用辅料油酸乙酯的脂肪酸组成。方法:采用聚乙二醇毛细管柱HP-INNOWAX(0.25 mm×30 m,25μm),起始温度为178℃,维持2 min,以每分钟3.3℃的速率升温至240℃,维持2.5 min,进样口温度为250℃,检测器温度为270℃。结果:油酸乙酯、棕榈酸乙酯、硬脂酸乙酯和亚油酸乙酯能完全分离,线性关系好,均大于0.9999,且方法重复性、灵敏度好。结论:使用该方法对供试品中油酸乙酯、棕榈酸乙酯、硬脂酸乙酯和亚油酸乙酯进行测定,可全面有效地控制药用辅料油酸乙酯的质量。Objective:To develop a method for the direct determination of fatty acids composition in ethyl oleate by gas chromatography(GC).Methods:The test was performed in capillary column coated with polyethylene glycol HP-INNOWAX(0.25 mm×30 m,25μm)under the programmed temperature.The programmed temperature of column was as follows:starting temperature as 178℃for 2 min,then raising the temperature to 240℃at a rate of 3.3℃·min^(-1),and maintaining it for 2.5 min.The temperature of injection port was 250℃and the detector temperature was 270℃.Results:Ethyl oleate,ethyl palmitate,ethyl linoleate and ethyl stearate were separated completely by this method.There was good linearity with r>0.9999 for four ethyl fatty acids.The method had the good repeatability and sensitivity.Conclusion:It can control the quality of pharmaceutical excipient of ethyl oleate comprehensively and effectively to determine ethyl oleate,ethyl palmitate,ethyl linoleate and ethyl stearate with the established method.

关 键 词：气相色谱法 直接测定 脂肪酸组成 油酸乙酯 

分 类 号：R921.2[医药卫生—药学]