中国药物警戒 ›› 2015, Vol. 12 ›› Issue (8): 464-466.

• 质量与工艺研究 • 上一篇    下一篇

注射用聚山梨酯80中脂肪酸组成测定

任睿1, 李坤丽2, 张璐2, 李英2, 张园园2   

  1. 1. 广东省药品检验所,广东 广州 510000;
    2. 北京中医药大学中药学院,北京 100102
  • 收稿日期:2015-09-02 修回日期:2015-09-02 出版日期:2015-08-08 发布日期:2015-09-02
  • 通讯作者: 张园园,女,副教授,药品质量控制。E-mail：choenen@163.com
  • 作者简介:任睿,女,主管药师,药用辅料标准研究。

GC Determination of Fatty Acids in Polysorbate 80 for Injection

REN Rui1, LI Kun-li2, ZHANG Lu2, LI Ying2, ZHANG Yuan-yuan2   

  1. 1. Guangdong Institute for Drug Control, Guangdong Guangzhou 510000, China;
    2. School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100102, China
  • Received:2015-09-02 Revised:2015-09-02 Online:2015-08-08 Published:2015-09-02

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摘要： 目的 建立气相色谱法（GC法）测定注射用聚山梨酯80中脂肪酸组成。方法 采用直接进样GC法,色谱柱为DB-WAX毛细管柱,检测器为FID,载气为氮气,柱温250℃。结果 注射用聚山梨酯80中8种脂肪酸衍生的脂肪酸甲酯（肉豆蔻酸甲酯、棕榈酸甲酯、硬脂酸甲酯、油酸甲酯、亚油酸甲酯、花生酸甲酯、二十碳烯酸甲酯、山嵛酸甲酯）均呈现良好的线性关系,精密度、重复性RSD均<3%,加样回收率在96.5%~104.2%。结论 本法方法简便、灵敏、准确、重现性好,适用于注射用聚山梨酯80的质量控制。

关键词: 注射用聚山梨酯80, 脂肪酸, GC, 含量测定

Abstract: Objective To determine the contents of fatty acids in polysorbate 80 for injection by GC. Methods The GC system consisted of DB-WAX capillary column and the temperature was set at 250℃. The detector was FID using nitrogen as carrier gas. Results The fatty acid methyl esters (methyl myristate, methyl palmitate, methyl stearate, methyl oleate, methyl linoleate, methyl arachidate, methyl eicosenoate, methyl behenate) were separated with a good linearity in the sample size ranges. The average recoveries were 96.5%~104.2%. Conclusion This method is simple, feasible and reproducible. It can be used for the quality control of polysorbate 80 for injection.

Key words: polysorbate 80 for injection, fatty acids, GC, quantitive determination

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