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目的采用LC-MS/MS法测定人血浆中的米氮平。方法采用Ultimate C18色谱柱(50 mm×4.6 mm,5μm);流动相为甲醇-水-甲酸(80:20:0.05);流速0.2 mL.min-1;柱温为室温;多反应离子监测,正离子模式扫描,电喷雾离子源。血浆样品碱化后经二氯甲烷萃取进样。结果米氮平的线性范围为0.1~120 ng.mL-1,最低定量限为0.1 ng.mL-1。米氮平和内标的tR均为2.4 min,批内和批间RSD分别小于7.12%、9.01%,方法回收率和萃取回收率分别为103.77%~106.38%、84.86%~91.92%,基质效应为7.60%~10.32%。血浆样品-30℃下保存40 d、室温下放置5 h、反复冻融3次均稳定,血药浓度变化率小于±15%。结论所建方法简单、快速,可用于米氮平血药浓度、药物动力学及生物等效性的研究。
Objective To determine the amount of mirtazapine in human plasma by LC-MS / MS. The method was based on Ultimate C18 column (50 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol-water-formic acid (80:20:.05), the flow rate was 0.2 mL.min-1, Positive ion mode scanning, electrospray ionization source. Plasma samples were alkalified and extracted with methylene chloride. Results The linear range of mirtazapine was 0.1 ~ 120 ng.mL-1, the lowest limit of quantification was 0.1 ng.mL-1. The tR of mirtazapine and internal standard were both 2.4 min. The RSDs within and between batches were less than 7.12% and 9.01%, respectively. The recoveries and recoveries were 103.77% -106.38% and 84.86% -91.92%, respectively. The matrix effects were 7.60 % ~ 10.32%. Plasma samples were stored at -30 ° C for 40 days, left at room temperature for 5 hours and frozen and thawed repeatedly for 3 times. The plasma concentration was less than ± 15%. Conclusion The method is simple and rapid and can be used to study the plasma concentration, pharmacokinetics and bioequivalence of mirtazapine.