A method for rapid analysis of polysorbate 80 components

ZHOU Ying; ZHAO Xun; HU Nan; WANG Baocheng; YUAN Yaozuo

doi:10.11665/j.issn.1000-5048.20220209

Journal of China Pharmaceutical University > 2022 > 53(2): 192-199. > DOI: 10.11665/j.issn.1000-5048.20220209

ZHOU Ying, ZHAO Xun, HU Nan, WANG Baocheng, YUAN Yaozuo. A method for rapid analysis of polysorbate 80 components[J]. Journal of China Pharmaceutical University, 2022, 53(2): 192-199. DOI: 10.11665/j.issn.1000-5048.20220209

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A method for rapid analysis of polysorbate 80 components

ZHOU Ying^1,2,3,
ZHAO Xun^2,3,
HU Nan⁴,
WANG Baocheng⁵,
YUAN Yaozuo^1,2,3

1.
College of Pharmacy, Nanjing University of Chinese Medicine, Nanjing 210023
2.
Jiangsu Institute for Food and Drug Control, Nanjing 210019
3.
NMPA Key Laboratory for Impurity Profile of Chemical Drugs, Nanjing 210019
4.
Agilent Technologies, Beijing 100102
5.
Nanjing Well Pharmaceutical Co., Ltd., Nanjing 210009, China

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Received Date: January 24, 2022
Revised Date: March 14, 2022

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Abstract

Abstract

Due to the complex components of polysorbate 80, analysis is time-consuming and labor-intensive, so there is an urgent need to find a method for rapid analysis of polysorbate 80 components.In this study, 10 batches of samples collected from 3 domestic and foreign enterprises were analyzed by UHPLC-HRMS, with the being further results were analyzed by the ExcipientProfiler software and supplemented by the extended database.The results showed that the ExcipientProfiler software could quickly identify the [M+Na]⁺ peak in the mass spectrogram, and obtain the information of component distribution, the numbers of components and the degree of polymerization of the sample.Meanwhile, the numbers of components obtained by the ExcipientProfiler software could be used to distinguish the injection grade samples from the ordinary grade samples by systematic clustering analysis.In addition, it was found through further supplement that the sample contained other fatty acid ester components by manually searching the relevant extended database.The polyoxyethylene sorbitan tetraoleate components were found in the sample according to the analysis of mass spectrum data.Therefore, although this method is fast and simple, it is necessary to add polyoxyethylene sorbitan tetraoleate components and other fatty acid ester components to further supplement the information in the ExcipientProfiler software, so that it can be better used for the analysis of polysorbate 80.
- polysorbate 80,
- components analysis,
- ExcipientProfiler software,
- database,
- cluster analysis

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