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建立简便、可靠、灵敏的同位素稀释质谱法测定血浆中奥氮平的浓度。50μL血浆样品中加入稳定同位素(奥氮平-D3)为内标,经特丁基甲醚提取后进样分析。色谱柱为XBridge Shield RP 18(100mm×2.1mm,3.5μm,Waters)。乙腈-缓冲液(氨水-醋酸铵,pH8)为流动相,等度洗脱,流速0.4mL·min-1。扫描方式为正离子多离子反应监测(MRM)。定量下限均为0.1ng·mL-1,线性范围为0.1～30ng·mL-1。对特异性、线性、准确度、精密度、回收率、介质效应均进行了方法学考察,且各项结果均符合要求,可以用于奥氮平的生物等效性研究。
A simple, reliable and sensitive isotope dilution mass spectrometry was established for the determination of olanzapine in plasma. 50μL plasma samples by adding stable isotopes (olanzapine-D3) as an internal standard, extracted with tert-butyl methyl ether injection analysis. The column was XBridge Shield RP 18 (100 mm × 2.1 mm, 3.5 μm, Waters). Acetonitrile-buffer (ammonia-ammonium acetate, pH8) as the mobile phase, isocratic elution, flow rate 0.4mL · min-1. The scanning method is positive ion multi-ion reaction monitoring (MRM). The lower limit of quantification was 0.1 ng · mL-1 and the linear range was 0.1-30 ng · mL-1. Methodological studies were conducted on specificity, linearity, accuracy, precision, recovery, and media effects, and the results were satisfactory and could be used for the bioequivalence study of olanzapine.