Chinese Journal of Pharmacovigilance ›› 2015, Vol. 12 ›› Issue (8): 464-466.

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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

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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