山西医科大学学报2025，Vol.56Issue(11)：1279-1286,8.DOI:10.13753/j.issn.1007-6611.2025.11.010
基于十二烷基硫酸钠/十六烷基硫酸钠的毛细管电泳方法的建立和验证
Establishment and validation of a capillary electrophoresis method based on sodium dodecyl sulfate/sodium hexadecyl sulfate
摘要
Abstract
Objective To establish a capillary electrophoresis method based on sodium dodecyl sulfate(SDS)and sodium hexadecyl sulfate(SHS)for purity analysis of Pertuzumab and Mepolizumab.Methods Based on the capillary electrophoresis-SDS(CE-SDS)method documented in Pharmacopoeia of the People's Republic of China(2025 edition),the concentration of SHS added to the SDS sample buffer and gel buffer was optimized.Acceptance criteria for method validation were established,and the specificity,range,accuracy,and precision of the optimized method were validated.Results The addition of 0.2%SHS to both gel buffer and sample buffer effectively eliminated the abnormal increase in aggregate content caused by CE-SDS method.The method demonstrated good specificity,with linear correlation coefficients(R²)all greater than 0.99.The reportable range for specific fragment was 2.22%-3.37%,and that for the main peak was not less than 86.53%.The injection time range was 10-60 s.The limit of quantification of the method was 0.33%.The recovery rates for specific fragment of each sample ranged from 91%to 105%,while the recovery rates of the main peak ranged from 98%to 104%.The RSD values for repeatability and intermediate precision of instrument linearity samples(L2-L7)and analytical linearity samples(S2-S6)were all less than 20%.Conclusion The established SDS/SHS-based capillary electro-phoresis method can be used to determine molecular size heterogeneity in Pertuzumab and Mepolizumab,which can accurately re-flect the purity and the aggregate content in samples.关键词
毛细管电泳/帕妥珠单抗/美泊利珠单抗/CE-SDS/SHS/方法学验证Key words
capillary electrophoresis/Pertuzumab/Mepolizumab/CE-SDS/SHS/methodological validation分类
医药卫生引用本文复制引用
YANG Yalan,QI Zhiyun,LI Meng,NI Yongbo,CUI Yongfei,YU Chuanfei..基于十二烷基硫酸钠/十六烷基硫酸钠的毛细管电泳方法的建立和验证[J].山西医科大学学报,2025,56(11):1279-1286,8.基金项目
国家重点研发计划项目(2021YFF0600804) （2021YFF0600804）
