LC-MS/MS法测定注射剂中来自生产管路中的PFOA和PFOS的迁移量  

Determination of the Migration of PFOA and PFOS from Manufacture Pipeline in Injections by LC-MS/MS

作　　者：张晓芸 张建茹 崔萍[1] 昝艳楠 曹庆丰 丁逸梅[1,2] ZHANG Xiaoyun;ZHANG Jianru;CUI Ping;ZAN Yannan;CAO Qingfeng;DING Yimei(Jiangsu Provincial Institute of Material Medica,Nanjing Tech University,Nanjing 210009,China;School of Pharmaceutical Sciences,Nanjing Tech University,Nanjing 211816,China)

机构地区：[1]南京工业大学江苏省药物研究所,南京210009 [2]南京工业大学药学院,南京211816

出　　处：《药学与临床研究》2020年第5期329-332,337,共5页Pharmaceutical and Clinical Research

摘　　要：目的:建立LC-MS/MS法测定注射剂制备时迁移至管路中的全氟辛酸(PFOA)和全氟辛基磺酸(PFOS)的含量。方法:采用色谱柱Kromasil C8(150 mm×3.0 mm,5μm),以0.01 mol·mL-1乙酸铵-乙腈(50∶50,v/v)为流动相。采用电喷雾离子源(ESI)、负离子模式检测方式进行定量分析。结果:PFOA和PFOS在5~50 ng·mL^-1范围内线性良好(r>0.999 0);PFOA回收率在90.92%~119.2%,PFOS回收率在80.93%~104.9%。结论:采用LC-MS/MS法测定注射剂中来自生产管路的PFOA和PFOS的含量,通过标准加入法能够消除注射剂复杂基体效应对PFOA和PFOS测定的影响,简便、快速地测定PFOA和PFOS的迁移量。Objective:To establish an LC-MS/MS method for the determination of PFOS and PFOA in injections from manufacture pipeline.Methods:A Kromasil C8 column(150 mm×3.0 mm,5μm)was applied for LC with 0.01 mol·mL-1 ammonium acetate-acetonitrile(50∶50,v/v)as the mobile phase.MS/MS quantitative analysis was carried out by using the electric spray ion source(ESI)and the negative ion mode detection method.Results:PFOS and PFOA in the coated stopper of QT liposome injections were linear in the range of 5-50 ng·mL^-1(r>0.999);the recovery of PFOA was between 90.92%and 119.2%,the recovery of PFOS was between 80.93%and 104.9%.Conclusion:The established LC-MS/MS method can determine PFOS and PFOA in injections from manufacture pipeline.The matrix effect from injection drugs can be removed by using a standard addition method.The method is accurate,easy and effective.

关 键 词：液相色谱-质谱联用技术 全氟辛酸(PFOA) 全氟辛基磺酸(PFOS) 迁移 生产管路 

分 类 号：R927.11[医药卫生—药学]