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目的:建立大鼠血浆中兰索拉唑及其代谢产物5-羟基兰索拉唑、兰索拉唑砜的HPLC-MS/MS测定方法。方法:色谱条件:色谱柱:Diamonsil C_(18)柱(150 mm×2.1 mm,5μm);流动相:乙腈-水(含0.01%甲酸及2 mmol·L~(-1)的醋酸铵(43:57,V/V);流速:0.3 ml·min~(-1);柱温:40℃;进样量10μl。质谱条件:电喷雾离子源(ESI),以多反应监测离子方式测定兰索拉唑及其代谢产物,选择性监测质荷比(m/z)为368.0/163.9(兰索拉唑),384.1/179.9(5-羟基兰索拉唑),383.9/115.9(兰索拉唑砜),326.0/280.1(内标奥美拉唑)。样品用乙腈沉淀蛋白处理。结果:兰索拉唑、5-羟基兰索拉唑、兰索拉唑砜的线性范围分别为11.40～4560.00,1.26～504.00,1.24～496.00 ng·ml~(-1);定量下限分别为11.40,1.26,1.24 ng·ml~(-1);批内、批间精密度RSD均<15%。结论:该方法灵敏、准确、快速、专属性好,适用于兰索拉唑及其代谢产物在大鼠体内的药代动力学研究。
Objective: To establish a HPLC-MS / MS method for the determination of lansoprazole and its metabolites 5-hydroxy-lansoprazole and lansoprazole sulfone in rat plasma. Methods: The chromatographic conditions were as follows: Diamonsil C 18 column (150 mm × 2.1 mm, 5 μm); mobile phase consisted of acetonitrile-water containing 0.01% formic acid and 2 mmol·L -1 ammonium acetate : 57, V / V); flow rate: 0.3 ml · min -1; column temperature: 40 ℃; injection volume 10μl. Mass spectrometry conditions: Electrospray ionization (ESI) Sorazole and its metabolites were selectively monitored for m / z 368.0 / 163.9 (lansoprazole), 384.1 / 179.9 (5-hydroxylansoprazole), 383.9 / 115.9 Azole sulfone), 326.0 / 280.1 (internal standard omeprazole) .The samples were treated with acetonitrile precipitated protein.Results: The linear range of lansoprazole, 5-hydroxy lansoprazole and lansoprazole sulfone were 11.40 ~ 4560.00,1.26 ~ 504.00,1.24 ~ 496.00 ng · ml ~ (-1), the lower limit of quantification was 11.40,1.26,1.24 ng · ml ~ (-1), respectively, and the intra-assay and inter-assay RSDs were all less than 15%. : The method is sensitive, accurate, rapid and specific, suitable for the study of pharmacokinetics of lansoprazole and its metabolites in rats.