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Rapid Analysis of Fatty Acid Composition in Polysorbate 80 by Gas Chromatography with On-line Pyrolytic Methylation Technique

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Abstract

A novel method of on-line pyrolytic methylation–gas chromatography was developed for the rapid analysis of fatty acid composition in Polysorbate 80 without any tedious pre-treatment steps. Fatty acids in Polysorbate 80 were converted into their corresponding fatty acid methyl esters in the presence of trimethylsulfonium hydroxide with a vertical microfurnace pyrolyzer at 300 °C. The premixing procedure of sample and organic alkali reagent was necessary before the on-line pyrolytic methylation to improve the repeatability. The relative standard deviations for peak areas of fatty acids in Polysorbate 80 were over the range of 0.3–9.1% (n = 5). Six Polysorbate 80 samples, consisting of three samples of pharmaceutical grade and three samples of non-pharmaceutical grade, were analyzed to evaluate the feasibility of the proposed method. The relative percentages (%) of fatty acids for samples of pharmaceutical grade meet the Chinese Pharmacopoeia requirements with the amount of oleic acid varying from 78.4 to 89.3%. On the other hand, the relative percentages (%) for palmitic acid and stearic acid in samples of non-pharmaceutical grade were out of the specification limits, with the amount of oleic acid varying from 62.0 to 63.5%. The quantitative results determined by on-line pyrolytic methylation were in agreement with those obtained by off-line methylation. The result proved that gas chromatography with on-line pyrolytic methylation technique is of great value for rapid screening analysis of Polysorbate 80 samples in bulks.

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Acknowledgements

This research was financially supported by National Natural Science Foundation of China (No. 51,503,182), Analysis and Measurement Foundation of Zhejiang Province (No. 2017C37064), Key Laboratory Item of Furniture Inspection Technology of Zhejiang Province (No. 2016J01) and Zhejiang University of Technology Natural Science Foundation (No. 2014XY002).

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Authors and Affiliations

  1. College of Chemical Engineering, Zhejiang University of Technology, Hangzhou, 310014, China

    Zhongping Huang, Ruofeng Qiu, Yilei Huang, Huijun Liu, Zaifa Pan & Lili Wang

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  1. Zhongping Huang
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  2. Ruofeng Qiu
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  3. Yilei Huang
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  4. Huijun Liu
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  5. Zaifa Pan
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Correspondence to Zhongping Huang or Lili Wang.

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Huang, Z., Qiu, R., Huang, Y. et al. Rapid Analysis of Fatty Acid Composition in Polysorbate 80 by Gas Chromatography with On-line Pyrolytic Methylation Technique. Chromatographia 81, 669–675 (2018). https://doi.org/10.1007/s10337-018-3488-2

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