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目的:建立一种快速灵敏的液质联用方法定量比格犬血浆中去甲文拉法辛,并进行比格犬体内富马酸去甲文拉法辛药代动力学研究,同时与琥珀酸去甲文拉法辛比格犬体内药代参数进行对比。方法:样品处理采用叔丁基甲醚进行液液萃取,液相分离采用Agilent Eclipse Plus C18色谱柱(2.1 mm×100 mm,3.5μm),以乙腈-乙酸铵缓冲液(1 mmol/L)(体积比80∶20)进行等度洗脱。采用单次给药和多次给药试验进行比格犬体内药代动力学研究。结果:此方法具有良好的线性、精密度、准确度,定量下限(0.5 ng/mL)高于文献报道。液液萃取的样品提取方法简便,液质联用分析时间相对较短(3 min)。结论:此方法可成功地应用于比格犬血浆中去甲文拉法辛定量分析。比格犬体内富马酸去甲文拉法辛的药代参数(单次给药和多次给药试验)与对照品琥珀酸去甲文拉法辛没有明显的统计学差异。
OBJECTIVE: To establish a rapid and sensitive LC-MS method for the determination of desvenlafaxine in Beagle dogs plasma and study the pharmacokinetics of desvenlafaxine fumarate in beagle dogs. Acid desvenlafaxin beagle dogs in vivo pharmacokinetic parameters were compared. Methods: The sample was treated with tert-butyl methyl ether for liquid-liquid extraction. The liquid phase was separated on a Agilent Eclipse Plus C18 column (2.1 mm × 100 mm, 3.5 μm) with acetonitrile-ammonium acetate buffer (1 mmol / L) 80:20) for isocratic elution. Beagle dogs’ pharmacokinetic studies were performed in single and multiple doses. Results: This method has good linearity, precision and accuracy. The lower limit of quantitation (0.5 ng / mL) was higher than that reported in the literature. Liquid-liquid extraction of sample extraction method is simple, liquid-liquid analysis time is relatively short (3 min). Conclusion: This method can be successfully applied to quantitative analysis of desvenlafaxine in Beagle dog plasma. The pharmacokinetic parameters of desvenlafaxine fumarate in Beagle dogs (single-dose and multiple-dose administration) were not significantly different from the reference product, desvenlafaxine succinate.