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DOI10.1016/j.chroma.2008.11.017
Quantitation of polysorbate 20 in protein solutions using mixed-mode chromatography and evaporative light scattering detection
Hewitt, Daniel; Zhang, Taylor; Kao, Yung-Hsiang
通讯作者Zhang, Taylor
来源期刊JOURNAL OF CHROMATOGRAPHY A
ISSN0021-9673
EISSN1873-3778
出版年2008
卷号1215期号:1-2页码:156-160
英文摘要

An HPLC assay requiring no complex sample preparation for the measurement of polysorbate 20 in protein solutions was developed. An on-off chromatography technique was employed involving a mixed-mode stationary phase (Waters Oasis MAX, mixed-mode anion-exchange and reversed-phase sorbent) to quantify polysorbate 20 in solutions containing >100 mg/mL of protein. With 2% formic acid mobile phase, proteins are typically positive charged and are not retained because of electrostatic repulsions from the quaternary amine in the mixed-mode resin. Other formulation components elute in void volume because of their hydrophilicity. Hydrophobic polysorbate 20 is retained, eluted with a step gradient and quantified as a single peak using an evaporative light scattering detector. The performance of the assay is evaluated according to International Conference on Harmonisation (ICH) guidelines and shown to be suitable for polysorbate quantitation. Accuracy (96-108%) and repeatability (2.3% RSD) were demonstrated using protein samples spiked with polysorbate 20. This method was used to accurately measure polysorbate 20 in at least 25 different protein solutions spanning a wide range of formulations. Although the majority of the data reported here target polysorbate 20, this methodology can also be used to assay other common non-ionic surfactants such as polysorbate 80, Brij, Igepal, and Triton X-100. (C) 2008 Elsevier B.V. All rights reserved.


英文关键词Polysorbate Mixed-mode chromatography Evaporative light scattering detection Protein Sample preparation
类型Article
语种英语
国家USA
收录类别SCI-E
WOS记录号WOS:000261845500020
WOS关键词PERFORMANCE LIQUID-CHROMATOGRAPHY ; FORMULATIONS
WOS类目Biochemical Research Methods ; Chemistry, Analytical
WOS研究方向Biochemistry & Molecular Biology ; Chemistry
资源类型期刊论文
条目标识符http://119.78.100.177/qdio/handle/2XILL650/158062
作者单位Genentech Inc, Prot Analyt Chem, San Francisco, CA 94080 USA
推荐引用方式
GB/T 7714
Hewitt, Daniel,Zhang, Taylor,Kao, Yung-Hsiang. Quantitation of polysorbate 20 in protein solutions using mixed-mode chromatography and evaporative light scattering detection[J],2008,1215(1-2):156-160.
APA Hewitt, Daniel,Zhang, Taylor,&Kao, Yung-Hsiang.(2008).Quantitation of polysorbate 20 in protein solutions using mixed-mode chromatography and evaporative light scattering detection.JOURNAL OF CHROMATOGRAPHY A,1215(1-2),156-160.
MLA Hewitt, Daniel,et al."Quantitation of polysorbate 20 in protein solutions using mixed-mode chromatography and evaporative light scattering detection".JOURNAL OF CHROMATOGRAPHY A 1215.1-2(2008):156-160.
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