山西医科大学学报2025，Vol.56Issue(4)：429-434,6.DOI:10.13753/j.issn.1007-6611.2025.04.012
高效液相色谱-电喷雾法测定单克隆抗体药物中泊洛沙姆188的含量
Determination of Poloxamer 188 content in monoclonal antibody drugs by HPLC-CAD
摘要
Abstract
Objective To establish a method for the determination of Poloxamer 188 content in monoclonal antibody drugs by high performance liquid chromatography-charged aerosol detector(HPLC-CAD).Methods The method for detecting Poloxamer 188 con-tent was established by HPLC-CAD,and the specificity,linearity,accuracy,intermediate precision,reproducibility and robustness of the method were validated.Results The specificity of the method was strong.The content of Poloxamer 188 and the peak area of the samples were linearly correlated in the range of 2.5-80 μg/mL,with a coefficient of determination R2>0.99.The recoveries of the seven validation solutions with different Poloxamer 188 contents(2.5,5,10,20,40,60,80 μg/mL)were in the range of 90%-110%.The seven validation solutions were each subjected to three independent measurements at three different working days,and the RSDs were 5.01%,4.77%,1.06%,1.42%,1.37%,0.37%and 0.45%,respectively.The validation solution at a concentration of 40 μg/mL was injected repeatedly six times,and the RSD of Poroxamer 188 concentration was 0.61%.The RSD of Poroxamer 188 concentration was 0.52%for validation solution at a concentration of 40 μg/mL after storage for 0 h and 24 h at room temperature.Conclusion A HPLC-CAD method for content determination of Poloxamer 188 in monoclonal antibody drugs is successfully developed with good reproducibility,specificity,precision and accuracy,which allows quality control for Poloxamer 188 content in monoclonal antibody drugs.关键词
高效液相色谱/电喷雾检测器/单克隆抗体药物/泊洛沙姆188/辅料/质量控制Key words
high performance liquid chromatography/charged aerosol detector/monoclonal antibody drugs/Poloxamer 188/excipient/quality control分类
医药卫生引用本文复制引用
崔春博,倪永波,武刚,李萌,俞小娟,徐刚领,崔永霏,郭璐韵,于传飞..高效液相色谱-电喷雾法测定单克隆抗体药物中泊洛沙姆188的含量[J].山西医科大学学报,2025,56(4):429-434,6.基金项目
国家重点研发计划项目(2021YFF0600804) （2021YFF0600804）
