反相高效液相色谱法(RP-HPLC-ELSD)测定重组蛋白注射剂中聚山梨酯20含量  

Determination of Polysorbate 20 in Recombinant Protein Injection by Rp-hplc-elsd

作　　者：张婷婷 鲁锐 杨新磊[1] Zhang Tingting;Lu Rui;Yang Xinlei(Agilent Technology(China)Co.,Ltd.Shanghai first branch,Shanghai 200080,China)

机构地区：[1]安捷伦科技(中国)有限公司上海第一分公司,上海200080

出　　处：《科学技术创新》2022年第5期9-12,共4页Scientific and Technological Innovation

摘　　要：介绍了利用Agilent1260 InfinityⅡ四元液相色谱系统、Agilent1290InfinityⅡELSD检测器和Agilent Poroshell120 SB-C18, 3.0 mm×150 mm, 2.7μm色谱柱对PEG偶联重组蛋白注射剂中的聚山梨酯20(吐温20)进行定量分析的简单灵敏的方法。该方法采用含三氟乙酸(0.1%TFA)的乙腈和水溶液为流动相,以梯度条件对注射剂中吐温20进行分离分析。该方法操作方便,灵敏度高,具有良好的线性关系、精密度和准确度,为生物制药企业测定PEG偶联的一类重组蛋白制剂中的吐温20辅料提供一种可选的解决方案。This paper introduces the use of Agilent 1260 infinity Ⅱ four component liquid chromatography system,Agilent 1290 infinity Ⅱ ELSD detector and Agilent poroshell 120 sb-c18, 3.0 mm × 150 mm, 2.7 μ M column is a simple and sensitive method for quantitative analysis of polysorbate 20(Tween 20) in PEG coupled recombinant protein injection. In this method, acetonitrile containing trifluoroacetic acid(0.1% TFA) and aqueous solution were used as mobile phase, and Tween 20 in injection was separated and analyzed under gradient conditions. The method has the advantages of convenient operation, high sensitivity, good linear relationship, precision and accuracy. It provides an optional solution for Biopharmaceutical Enterprises to determine Tween 20 excipients in a class of PEG coupled recombinant protein preparations.

关 键 词：RP-HPLC-ELSD 聚山梨酯20 测定 

分 类 号：R927[医药卫生—药学]