【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=6 213x+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。更多还原

【Abstract】 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, 1.7 μm） 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 0.5 μg·mL^–1, the standard curve linear range was good in the range 0.5-50 μg·mL^–1 with the linear regression equation was y=6 213x+197（r²>0.999）, the average recovery of the pretreatment was greater than 99%; the precision within the batch was1.70%-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.更多还原