山西医科大学学报2025，Vol.56Issue(10)：1155-1159,5.DOI:10.13753/j.issn.1007-6611.2025.10.007
高效液相色谱法测定单抗药物中的Triton X-100含量
Determination of Triton X-100 content in monoclonal antibody drugs by HPLC
摘要
Abstract
Objective To establish a method for the determination of Triton X-100 content in monoclonal antibody drugs by high per-formance liquid chromatography(HPLC).Methods The method for detecting Triton X-100 content was established by HPLC,and the specificity,linearity,accuracy,intermediate precision,reproducibility and robustness of the method were validated.Results The specificity of the method was strong.The Triton X-100 contents and the peak areas of the samples were linearly correlated in the range of 10-100 μg/mL,with a coefficient of determination R2>0.99.The recoveries of the six validation solutions with different Triton X-100 contents(10,20,30,50,70,100 μg/mL)were in the range of 90%-115%.Three independent determinations were carried out on three different working days for each of the six validation solutions mentioned above,and the RSDs for their concentrations were 4.44%,2.39%,2.60%,0.95%,0.47%and 0.54%,respectively.The injection was repeated six times for the 20 μg/mL concentration level validation solution,and the RSD for Triton X-100 content determination was 1.08%.The coefficient of variation for Triton X-100 content determination by different columns was 4.63%.Conclusion The developed method is sensitive and accurate to determine Triton X-100 content,which can be used for quality control in monoclonal antibody drugs.关键词
高效液相色谱/方法学验证/单克隆抗体药物/Triton X-100/质量控制Key words
high performance liquid chromatography/methodological validation/monoclonal antibody drugs/Triton X-100/quality control分类
医药卫生引用本文复制引用
崔春博,于传飞,倪永波,杜加亮,武刚,徐刚领,陈浩彬,俞小娟,郭璐韵,蔡蓁..高效液相色谱法测定单抗药物中的Triton X-100含量[J].山西医科大学学报,2025,56(10):1155-1159,5.基金项目
国家重点研发计划项目(2021YFF0600804) （2021YFF0600804）
