米托坦人血浆浓度的UPLC快检及治疗药物监测  

Rapid determination of mitotane in human plasma by UPLC and therapeutic drug monitoring

作　　者：蒋鑫 肖丹[3] 邸相杰 梁秀芳 秦永平[2] 钱广生[1] JIANG Xin;XIAO Dan;DI Xiangjie;LIANG Xiufang;QIN Yongping;QIAN Guangsheng(West China School of Pharmacy Sichuan University,Chengdu 610041,China;Clinical Pharmacology Lab,Clinical Trial Center,WCH,SCU,Chengdu 610041,China;the Fifth Clinical College of Chongqing Medical University,Chongqing 400016,China;South China University of Technology,Guangzhou 510641,China)

机构地区：[1]四川大学华西药学院,四川成都610041 [2]四川大学华西医院临床试验中心临床药理研究室,四川成都610041 [3]重庆医科大学第五临床医学院,重庆400016 [4]华南理工大学,广东广州510641

出　　处：《中国测试》2023年第11期96-101,共6页China Measurement & Test

摘　　要：建立一种超高效液相色谱-紫外法(UPLC-UV)快速测定米托坦血浆中治疗药物浓度监测(TDM)的方法。血浆样本经乙腈沉淀蛋白后,采用色谱柱为C18(2.1 mm×50 mm,1.7μm),流动相:乙腈∶水(78∶22,v/v),流量:0.3 mL·min^(–1),柱温40℃,在波长为230 nm处检测,外标法定量。米托坦保留时间为1.38 min,定量限(LOQ)为0.5μg·mL−1,线性范围为0.5~50μg·mL^(–1)、线性回归方程为y=6213x+197(r2>0.999),平均回收率均大于99%;批内精密度在1.70%~6.63%之间,准确度在–6.56%~11.08%之间;批间精密度在3.99%~8.64%之间,准确度在–0.62%~1.90%之间。该方法快速简便,准确度高,适用于临床上米托坦血浆药物浓度的监测。An ultra-performance liquid chromatography-ultraviolet(UPLC-UV)method for the rapid determination of mitotane in plasma was established in therapeutic drug monitoring.The plasma samples were separated by C18(2.1 mm×50 mm,1.7μm)column after precipitating the protein with acetonitrile,and eluted by using acetonitrile∶water(78∶22,v/v)as mobile phase with a flow rate of 0.3 mL·min^(–1)and a column temperature of 40℃.It was detected at a wavelength of 230 nm and quantified by the external standard method.Mitotane retention time was 1.38 min,the limit of quantitation(LOQ)was 0.5μg·mL^(–1),the standard curve linear range was good in the range 0.5-50μg·mL^(–1)with the linear regression equation was y=6213x+197(r2>0.999),the average recovery of the pretreatment was greater than 99%;the precision within the batch was 1.70%-6.63%,and the accuracy was–6.56%-11.08%,the inter-batch precision was 3.99%-8.64%,and the accuracy was–0.62%-1.90%.This method is sensitive,accurate,fast and simple,and suitable for the clinical monitoring of mitotane concentration in plasma.

关 键 词：米托坦 超高效液相色谱法 临床监测 血药浓度 

分 类 号：TB9[一般工业技术—计量学] R969.1[机械工程—测试计量技术及仪器]