Discrimination of polysorbate 20 by high-performance liquid chromatography-charged aerosol detection and characterization for components by expanding compound database and libraryOA
Discrimination of polysorbate 20 by high-performance liquid chromatography-charged aerosol detection and characterization for components by expanding compound database and library
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.
Shi-Qi Wang;Yaozuo Yuan;Mei Zhang;Hian Kee Lee;Hai-Wei Shi;Xun Zhao;Li-Jun Zhang;Yue-Mei Zhao;Lei Chen;Jin-Lin Zhang;Bao-Cheng Wang;Sheng Tang;Tom Yuan
Jiangsu Institute for Food and Drug Control,Nanjing,210019,China||School of Pharmacy,China Pharmaceutical University,Nanjing,211112,ChinaJiangsu Institute for Food and Drug Control,Nanjing,210019,ChinaSchool of Environmental and Chemical Engineering,Jiangsu University of Science and Technology,Zhenjiang,Jiangsu,212003,China||Department of Chemistry,National University of Singapore,Singapore,117543,SingaporeJiangsu Institute for Food and Drug Control,Nanjing,210019,China||School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing,210046,ChinaChinese Pharmacopoeia Commission,Beijing,100061,ChinaNanjing Well Pharmaceutical Group Co.,Ltd.,Nanjing,210018,ChinaSchool of Environmental and Chemical Engineering,Jiangsu University of Science and Technology,Zhenjiang,Jiangsu,212003,ChinaUniversity of Massachusetts Amherst,Amherst,01003,USA
Polysorbate 20ComponentDatabaseDiscriminationDegradation
《药物分析学报（英文）》 2024 (005)
722-732 / 11
The authors are grateful for the financial support from the Sci-ence Research Program Project for Drug Regulation,Jiangsu Drug Administration,China(Grant No.:202207),the National Drug Standards Revision Project,China(Grant No.:2023Y41),the Na-tional Natural Science Foundation of China(Grant No.:22276080),and the Foreign Expert Project,China(Grant No.:G2022014096L).
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