首页|Discrimination of polysorbate 20 by high-performance liquid chromatography-charged aerosol detection and characterization for components by expanding compound database and library

Discrimination of polysorbate 20 by high-performance liquid chromatography-charged aerosol detection and characterization for components by expanding compound database and library

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  • 国家科技期刊平台
  • NETL
  • NSTL
  • 万方数据
Analyzing polysorbate 20(PS20)composition and the impact of each component on stability and safety is crucial due to formulation variations and individual tolerance.The similar structures and polarities of PS20 components make accurate separation,identification,and quantification challenging.In this work,a high-resolution quantitative method was developed using single-dimensional high-performance liquid chromatography(HPLC)with charged aerosol detection(CAD)to separate 18 key components with multiple esters.The separated components were characterized by ultra-high-performance liquid chro-matography-quadrupole time-of-flight mass spectrometry(UHPLC-Q-TOF-MS)with an identical gradient as the HPLC-CAD analysis.The polysorbate compound database and library were expanded over 7-time compared to the commercial database.The method investigated differences in PS20 samples from various origins and grades for different dosage forms to evaluate the composition-process relationship.UHPLC-Q-TOF-MS identified 1329 to 1511 compounds in 4 batches of PS20 from different sources.The method observed the impact of 4 degradation conditions on peak components,identifying stable components and their tendencies to change.HPLC-CAD and UHPLC-Q-TOF-MS results provided insights into fingerprint differences,distinguishing quasi products.

Polysorbate 20ComponentDatabaseDiscriminationDegradation

Shi-Qi Wang、Xun Zhao、Li-Jun Zhang、Yue-Mei Zhao、Lei Chen、Jin-Lin Zhang、Bao-Cheng Wang、Sheng Tang、Tom Yuan、Yaozuo Yuan、Mei Zhang、Hian Kee Lee、Hai-Wei Shi

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Jiangsu Institute for Food and Drug Control,Nanjing,210019,China

School of Pharmacy,China Pharmaceutical University,Nanjing,211112,China

School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing,210046,China

Chinese Pharmacopoeia Commission,Beijing,100061,China

Nanjing Well Pharmaceutical Group Co.,Ltd.,Nanjing,210018,China

School of Environmental and Chemical Engineering,Jiangsu University of Science and Technology,Zhenjiang,Jiangsu,212003,China

University of Massachusetts Amherst,Amherst,01003,USA

Department of Chemistry,National University of Singapore,Singapore,117543,Singapore

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science Research Program Project for Drug Regulation,Jiangsu Drug Administration,ChinaNational Drug Standards Revision Project,ChinaNational Natural Science Foundation of ChinaForeign Expert Project,China

2022072023Y4122276080G2022014096L

2024

10.1016/j.jpha.2023.12.019

药物分析学报(英文)
西安交通大学

药物分析学报(英文)

影响因子：0.244
ISSN：2095-1779
年,卷(期)：2024.14(5)
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