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目的:建立测定人血浆中单硝酸异山梨酯的超高效液相色谱-飞行时间质谱联用法。方法:应用ACQUITY UPLC HssT3(1.8μm,2.1 mm×50 mm)色谱柱,以乙腈-0.1%甲酸水为流动相,梯度洗脱进行分离,流速0.50 mL·min-1。采用飞行时间质谱检测器,大气压电喷雾离子源(ESI),负离子全扫描检测。结果:血浆中内源性物质不干扰测定,每个样品分析时间为3.0 min,本法线性范围为0.02～1.00μg·mL-1,提取回收率为98.6%～109.0%,日内和日间的RSD分别小于8.7%和10.6%。结论:该方法灵敏、快速,重现性好,可用于单硝酸异山梨酯临床血药浓度监测和药动学研究。
Objective: To establish a method for the determination of isosorbide mononitrate in human plasma by ultra performance liquid chromatography-time of flight mass spectrometry. METHODS: ACQUITY UPLC HssT3 (1.8 μm, 2.1 mm × 50 mm) column was used with acetonitrile-0.1% formic acid as mobile phase and gradient elution. The flow rate was 0.50 mL · min-1. Time of flight mass spectrometry detector, atmospheric pressure electrospray ionization source (ESI), negative ion full scan detection. Results: The endogenous substances in plasma did not interfere with the determination. The time for each sample analysis was 3.0 min. The linear range of this method was 0.02-1.00 μg · mL-1. The recovery rate was 98.6% -109.0%. The intra- and inter-day RSD less than 8.7% and 10.6% respectively. Conclusion: The method is sensitive, rapid and reproducible. It can be used to monitor the blood concentration of isosorbide mononitrate and to study its pharmacokinetics.