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目的:建立以液-质联用(LC-MS)法测定人血浆中度洛西汀浓度的方法。方法:血浆样品0.2mL,用乙腈沉淀蛋白2次,以20mmol·L-1乙酸铵溶液(pH3.5)-甲醇-乙腈(38∶20∶42)为流动相,用ThermoC18柱分离,采用LC-MS法测定10名健康志愿者单剂量口服盐酸度洛西汀肠溶胶囊22.4、44.8、67.2mg后的血药浓度。结果:度洛西汀血药浓度在0.78～100ng.mL-1范围内线性关系良好(r=0.9995);平均方法回收率为100.8%,日内RSD≤7.8%,日间RSD≤9.3%。结论:本方法准确、灵敏,适用于度洛西汀的药动学研究。
Objective: To establish a method for the determination of duloxetine in human plasma by liquid chromatography-mass spectrometry (LC-MS). Methods: The plasma samples were separated by 0.2mL, the proteins were precipitated with acetonitrile twice with 20mmol·L-1 ammonium acetate solution (pH3.5) -methanol-acetonitrile (38:20:42) as mobile phase, -MS method to determine the blood concentration of 10 healthy volunteers single oral dose of oral duloxetine hydrochloride capsule 22.4,44.8,67.2mg. Results: The linear range of duloxetine was 0.78 ~ 100ng.mL-1 (r = 0.9995). The average recovery was 100.8%. The intra-day RSD was less than or equal to 7.8% and the intraday RSD was less than or equal to 9.3%. Conclusion: This method is accurate and sensitive, suitable for duloxetine pharmacokinetic studies.