一种检测曲拉通X-100残留的HPLC方法研究  

A HPLC Method for Detecting the Residues of Triton X-100

作　　者：刘元雪 高丽昌 张旭东 王品 李方敏 高伟伟 董芳芳 赵成如 张尚 LIU Yuan-xue;GAOLi-chang;ZHANG Xudong;WANG Pin;LI Fang-min;GAO Wei-wei;DONG Fang-fang;ZHAO Cheng-ru;ZHANG Shang(Success Bio-tech Co.,Ltd.,Jinan 250101,China;Shandong Biomedical Materials Engincering Laboratory,Jinan 250101,China)

机构地区：[1]赛克赛斯生物科技股份有限公司,山东济南250101 [2]山东省生物医用材料工程实验室,山东济南250101

出　　处：《当代化工》2022年第7期1752-1755,1760,共5页Contemporary Chemical Industry

基　　金：山东省重大科技创新工程,可吸收创面修复生物材料研发及产业化(项目号:2019JZZY011107)。

摘　　要：曲拉通X-100是生物制品制备过程中常用的表面活性剂,但是尚没有其高效液相色谱法(HPLC)的统一检测标准。本研究对其检测进行了方法学研究。用水对待测生物羊膜/绒毛膜材料样品进行24 h的浸提处理,以30%甲醇-水为流动相A、乙腈为流动相B,采用Waters Symmetry300 C18色谱柱(4.6 mm×150 mm,3.5μm),在流速1.0 mL·min^(-1)、检测波长230 nm、柱温40℃、进样量20μL的条件下进行检测。结果表明:曲拉通X-100质量浓度在0.0436~48.4242μg·mL^(-1)范围内与峰面积线性关系良好(R=0.9996);检测下限(S/N=3)为0.262 ng,定量下限(S/N=10)为0.873 ng,回收率为108.51%。本方法操作简便、准确、重复性好,可用于曲拉通X-100与前杂的分离和曲拉通X-100残留量检测。Triton X-100 is a commonly used surfactant in the preparation of biological products, but there is not established standard HPLC analysis method. In this study, the methodology research on Triton X-100 detection was carried out. The sample was extracted with water for 24 h, followed by HPLC detection using 30% methanol-water as mobile phase A and acetonitrile as mobile phase B, Waters Symmetry 300 C18 column (150 mm×4.6 mm, 3.5 μm) and a flow rate of 1.0 m L·min^(-1). The detection wavelength was 230 nm, the column temperature was 40℃ and the injection volume was 20 μL. Results showed that the linear relationship was good (R=0. 999 6) in the range of Triton X-100 mass concentration 0.043 6 μg·m L(limit of quantification) ~ 48.424 2 μg·m L^(-1);the detection limit (S/N = 3)was 0.262 ng;the limit of quantification (S/N = 10) was 0.873 ng;and the recovery rate was 108.51%. This method is simple, accurate and reproducible. It can be used for the HPLC separation of Triton X-100 and the detection of Triton X-100 residues.

关 键 词：羊膜/绒毛膜 曲拉通X-100 聚乙二醇辛基苯基醚 杂质残留检测 杂质分离 高效液相色谱法 

分 类 号：O657[理学—分析化学]