HPLC-荧光法测定单抗药物中聚山梨酯的含量  

Determination of the Content of Polysorbate in Monoclonal Antibody Formulation by HPLC-Fluorescence

作　　者：徐明明[1] 程菁 吴利红[1] 邵泓[1] 陈钢[1] XU Mingming;CHENG Jing;WU Lihong;SHAO Hong;CHEN Gang(NMPA Key Lab.for Quality Control of Therapeutic Monoclonal Antibodies,Shanghai Institute for Food and Drug Control,Shanghai 201203)

机构地区：[1]上海市食品药品检验所治疗类单抗质量控制重点实验室

出　　处：《中国医药工业杂志》2019年第9期1047-1051,共5页Chinese Journal of Pharmaceuticals

摘　　要：采用HPLC-FLD法测定9种单抗药物中的聚山梨酯20或聚山梨酯80含量,结果表明,HPLC-FLD法可用于聚山梨酯含量的测定,但是不能区分聚山梨酯20和聚山梨酯80,并且抗体的存在干扰聚山梨酯的含量测定,需要扣除抗体的干扰。An HPLC-FLD method was used for the determination of polysorbate 20 or polysorbate 80 in 9 monoclonal antibody formulations to study the interference of antibody in the monoclonal antibody formulation. In the results of HPLC-FLD, polysorbate 20 and polysorbate 80 could not be separated, and the presence of antibodies interfered with the determination of polysorbate content, so the interference of the antibody should be deducted.

关 键 词：HPLC-荧光法 聚山梨酯 单抗药物 

分 类 号：O657.72[理学—分析化学]