• 中国精品科技期刊
  • 中国高校百佳科技期刊
  • 中国中文核心期刊
  • 中国科学引文数据库核心期刊
Advanced Search
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
Citation: 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

A method for rapid analysis of polysorbate 80 components

More Information
  • Received Date: January 24, 2022
  • Revised Date: March 14, 2022
  • 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.
  • [1]
    . Chin J Pharm Anal(药物分析杂志),2017,37(2):320-325.
    [2]
    Ma HY,Li X,Zhang HY,et al. Progress of the physical and chemistry properties about tween-80 as the solubilization adjuvant in TCM injections[J]. Chin Pharm Aff(中国药事),2010,24(6):594-596.
    [3]
    Li Y,Zhang LM,Duan JL,et al. Advance of polysorbate 80 in injections[J]. J Yunnan Univ Tradit Chin Med(云南中医学院学报),2018,41(4):93-97.
    [4]
    Saha P,Kou JH. Effect of solubilizing excipients on permeation of poorly water-soluble compounds across Caco-2 cell monolayers[J]. Eur J Pharm Biopharm,2000,50(3):403-411.
    [5]
    Kerwin BA. Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways[J]. J Pharm Sci,2008,97(8):2924-2935.
    [6]
    Randolph TW,Jones LS. Surfactant-protein interactions[J]. Pharm Biotechnol,2002,13:159-175.
    [7]
    Gao ZS,Chen XG,Wu RR,et al. Synthesis of polysorbate 80 (Ⅰ) for injection:
    CN102127217A[P]. 2011-07-202022-02-23].
    [8]
    Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia:part 4(中华人民共和国药典:四部)[S]. Beijing: China Medical Science Press,2020: 808-809.
    [9]
    Ayorinde FO,Gelain SV,Johnson JH,et al. Analysis of some commercial polysorbate formulations using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry[J]. Rapid Commun Mass Spectrom,2000,14(22):2116-2124.
    [10]
    Wang Z,Wang YN,Tie C,et al. A fast strategy for profiling and identifying pharmaceutic excipient polysorbates by ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry[J]. J Chromatogr A,2020,1609:460450.
    [11]
    Zhang R,Wang Y,Tang L,et al. Analysis of the chemical composition of polysorbate 80[J]. Chin Pharm J(中国药学杂志),2012,47(2): 149-154.
    [12]
    Zhang Y,Wang Y,Deng XL,et al. Study of degranulation induced by the chemical composition of polysorbate 80 in a rat mast (RBL-2H3) cell line[J]. Chin Pharm J(中国药学杂志),2014,49(5):371-376.
    [13]
    Li C,Tu JS. Relationship between ingredient of polysorbate 80 and its hemolysis[J]. J China Pharm Univ(中国药科大学学报),2012,43(3):231-235.
    [14]
    Wu RR,Peng WY,Tu JS. Study on hemolysis of the ingredient of polysorbate 80[J]. Pharm Biotechnol(药物生物技术),2016,23(1):39-43.
    [15]
    Zhang R,Wang Y,Tan L,et al. Analysis of polysorbate 80 and its related compounds by RP-HPLC with ELSD and MS detection[J]. J Chromatogr Sci,2012,50(7):598-607.
    [16]
    Zhang R,Wang Y,Shi BJ,et al. HPLC/ELSD determination of oleic acid,polyoxyethylene isosorbide,polyoxyethylene sorbitan and polyoxyethylene sorbitol in polysorbate 80[J]. Chin J Pharm Anal(药物分析杂志),2013,33(6):994-998.
    [17]
    Zhang R,Wang Y,Ji Y,et al. Quantitative analysis of oleic acid and three types of polyethers according to the number of hydroxy end groups in Polysorbate 80 by hydrophilic interaction chromatography at critical conditions[J]. J Chromatogr A,2013,1272:73-80.
    [18]
    Hewitt D,Alvarez M,Robinson K,et al. Mixed-mode and reversed-phase liquid chromatography-tandem mass spectrometry methodologies to study composition and base hydrolysis of polysorbate 20 and 80[J]. J Chromatogr A,2011,1218(15):2138-2145.
    [19]
    Lippold S,Koshari SHS,Kopf R,et al. Impact of mono- and poly-ester fractions on polysorbate quantitation using mixed-mode HPLC-CAD/ELSD and the fluorescence micelle assay[J]. J Pharm Biomed Anal,2017,132:24-34.
    [20]
    Yang K,Hewarathna A,Geerlof-Vidavsky I,et al. Screening of polysorbate-80 composition by high resolution mass spectrometry with rapid H/D exchange[J]. Anal Chem,2019,91(22):14649-14656.
    [21]
    Pan JH,Ji Y,Du ZX,et al. Rapid characterization of commercial polysorbate 80 by ultra-high performance supercritical fluid chromatography combined with quadrupole time-of-flight mass spectrometry[J]. J Chromatogr A,2016,1465:190-196.
    [22]
    Zhang Q,Wang AF,Meng Y,et al. NMR method for accurate quantification of polysorbate 80 copolymer composition[J]. Anal Chem,2015,87(19):9810-9816.
    [23]
    Hvattum E,Yip WL,Grace D,et al. Characterization of polysorbate 80 with liquid chromatography mass spectrometry and nuclear magnetic resonance spectroscopy: specific determination of oxidation products of thermally oxidized polysorbate 80[J]. J Pharm Biomed Anal,2012,62:7-16.
  • Related Articles

    [1]MO Xinhe, WAN Youqiong, WANG Sibu, MA Qin, ZHANG Jun, CHEN Ying. Ameliorative effect of baicalin nanomedicine on hydrogen peroxide-induced senescence of human umbilical vein vascular endothelial cells[J]. Journal of China Pharmaceutical University, 2025, 56(1): 110-118. DOI: 10.11665/j.issn.1000-5048.2024052101
    [2]WANG Sibu, CHEN Ying, DING Yang, XIAO Ting, LIU Wen, SHEN Xiangchun, TAO Ling, LUO Xinghong. Preparation of paeonol nanoemulsion and investigation of vascular endothelial cells uptake[J]. Journal of China Pharmaceutical University, 2022, 53(6): 690-697. DOI: 10.11665/j.issn.1000-5048.20220607
    [3]DUAN Lanlan, DONG Jing, FAN Xiangcheng, ZHU Junyi, ZHANG Yifan, HAN Jichun, SHANG Jing. β-Elemene improves endothelial cells dysfunction, and abnormal proliferation and migration of vascular smooth muscle cells[J]. Journal of China Pharmaceutical University, 2020, 51(3): 333-339. DOI: 10.11665/j.issn.1000-5048.20200311
    [4]ZHU Chengyan, LIU Haochen, HE Hua, LIU Xiaoquan. Evaluating cerebral endothelial dysfunction induced by amyloid based on the time series model[J]. Journal of China Pharmaceutical University, 2018, 49(4): 456-462. DOI: 10.11665/j.issn.1000-5048.20180411
    [5]HE Shuying, XIONG Rui, LIU Kun, XU Yungen. Molecular mechanisms of combretastatin A-4 amino sugar derivative CPU-XT-008 on inhibiting proliferation of vascular endothelial cells[J]. Journal of China Pharmaceutical University, 2015, 46(5): 594-599. DOI: 10.11665/j.issn.1000-5048.20150513
    [6]LIU Yu, GU Yue, YUN Dong-jie, CHEN Jian-quan, LIU Si-guo, ZHANG Ai-min. Generation of fully human anti-vascular endothelial growth factor 165 monoclonal antibody with antitumor efficacy from transgenic five-feature mice[J]. Journal of China Pharmaceutical University, 2009, 40(3): 269-272.
    [7]Effects of Melatonin on the Immune Functions of Diabetic Rats Combined with Injury-induced Stress[J]. Journal of China Pharmaceutical University, 2004, (4): 71-74.
    [8]Effect of Lomerizine on the Activity of P-glycoprotein in Primary Cultured Rat Brain Microvessel Endothelial Cells[J]. Journal of China Pharmaceutical University, 2003, (4): 62-65.
    [9]Protective Effects of Shark Hepatic Stimulator Substance on Alloxan-induced Diabetes in Mice[J]. Journal of China Pharmaceutical University, 2003, (2): 59-63.
    [10]Influences on Serum Insulin and Glucose by Different Fasting Time in Alloxan Diabetic Mice[J]. Journal of China Pharmaceutical University, 2001, (3): 59-62.
  • Cited by

    Periodical cited type(2)

    1. 周德军,王珂洋,郝婷,张钰滢,赵桂琴. 三氮唑香豆素的合成进展. 化学研究与应用. 2024(04): 696-703 .
    2. 李卓远,史佳慧,刘楠,薛玉涛,李婉倩,蒋治坤,周佳雨,刘晖,熊山. 香豆素衍生物的生物活性研究进展. 精细与专用化学品. 2024(06): 23-30 .

    Other cited types(0)

Catalog

    Article views (223) PDF downloads (573) Cited by(2)

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return