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目的建立同时测定人血浆中苯海拉明、氯苯那敏、异丙嗪、氯雷他定、非索非那定、地氯雷他定、左西替利嗪、赛庚啶浓度的超高效液相色谱质谱(UPLC-MS/MS)法。方法以盐酸吡格列酮为内标,血浆经甲醇直接沉淀后进样分析,用UPLC-MS/MS法进行检测。色谱柱为ACQUITY UPLC HSS C18柱,流动相为含0.01%甲酸的水溶液-0.01%甲酸的甲醇溶液,流速为0.3 m L·min 230001,China,电喷雾离子源,用多反应监测,正离子分段扫描分析。结果苯海拉明、氯苯那敏、异丙嗪、氯雷他定、非索非那定、地氯雷他定、左西替利嗪、赛庚啶血药浓度分别在1.15×10~(-3)~2.30×10~(-1),2.48×10~(-4)~2.48×10~(-2),2.86×10~(-3)~2.86×10~(-1),2.50×10~(-4)~2.50×10~(-2),5.50×10~(-3)~2.20,2.20×10~(-4)~2.20×10~(-2),5.70×10~(-3)~2.28,3.50×10~(-3)~3.50×10~(-1)μg·m L~(-1)线性关系良好;最低定量下限分别为1.15×10~(-3),2.48×10~(-4),2.86×10~(-3),2.50×10~(-4),5.50×10~(-3),2.20×10~(-4),5.70×10~(-3),3.50×10~(-3)μg·m L~(-1)。日内、日间精密度RSD均<15%;提取回收率均>65%,RSD均<15%。结论该方法灵敏、快速、准确、专属性强,可用于上述8种抗组胺类药物的血药浓度监测及药代动力学研究。
Objective To establish a method for the simultaneous determination of diphenhydramine, chlorpheniramine, promethazine, loratadine, fexofenadine, desloratadine, levocetirizine and cyproheptadine in human plasma High performance liquid chromatography mass spectrometry (UPLC-MS / MS) method. Methods Pioglitazone hydrochloride was used as an internal standard. The plasma was directly precipitated by methanol and injected into the plasma and detected by UPLC-MS / MS. The column was ACQUITY UPLC HSS C18 column, the mobile phase consisted of 0.01% formic acid in water and 0.01% formic acid in methanol at a flow rate of 0.3 mL · min-230001, China. Electrospray ionization was performed with multiple reaction monitoring, Section scan analysis. Results The concentrations of diphenhydramine, chlorpheniramine, promethazine, loratadine, fexofenadine, desloratadine, levocetirizine and cyproheptadine were respectively 1.15 × 10 ~ (-3) ~ 2.30 × 10 ~ (-1), 2.48 × 10 ~ (-4) ~ 2.48 × 10 ~ (-2) and 2.86 × 10 ~ (-3) ~ 2.86 × 10 ~ (-1) 2.50 × 10 -4 to 2.50 × 10 -2 5.50 × 10 -3 to 2.20 and 2.20 × 10 -4 to 2.20 × 10 -2 5.70 × 10 ~ (-3) ~ 2.28,3.50 × 10 ~ (-3) ~ 3.50 × 10 ~ (-1) μg · m L ~ (-1), respectively. The lowest limits of quantitation were 1.15 × 10 ~ (-3) ), 2.48 × 10 -4, 2.86 × 10 -3, 2.50 × 10 -4, 5.50 × 10 -3, 2.20 × 10 -4, 5.70 × 10 ~ (-3), 3.50 × 10 ~ (-3) μg · m L ~ (-1). The intra-day and inter-day RSDs were <15%, and the recovery rates were both> 65% with RSD <15%. Conclusion The method is sensitive, rapid, accurate and specific. It can be used to monitor the blood concentration and pharmacokinetics of the eight antihistamines.