高效液相色谱法同时测定犬血浆中泮托拉唑及其两种代谢物

Simultaneous determination of pantoprazole and its two metabolites in dog plasma by HPLC.

作者信息

Xie Zhiyong, Chen Xiaoyan, Jin Fengdan, Zhong Dafang

机构信息

Laboratory of Drug Metabolism and Pharmacokinetics, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang 110016, P.R. China.

出版信息

J Chromatogr Sci. 2005 May-Jun;43(5):271-5. doi: 10.1093/chromsci/43.5.271.

DOI:10.1093/chromsci/43.5.271

PMID:15975247

Abstract

A simple and sensitive high-performance liquid chromatography (HPLC) method is developed and validated for simultaneous determination of pantoprazole and its two metabolites (pantoprazole sulfone and pantoprazole thioether) in dog plasma and applied to a pharmacokinetic study in Beagle dogs. Following a protein precipitation procedure, the samples are separated using reversed-phase HPLC (C18) by a gradient of acetonitrile and ammonium acetate (pH 6.0) at a flow rate of 1.0 mL/min and quantitated using UV detection at 290 nm. Omeprazole is selected as the internal standard. The method has a lower limit of quantitation of 0.025 microg/mL for pantoprazole and its two metabolites, using 0.1-mL aliquots of plasma. The linear calibration curves are obtained in the concentration range of 0.025-10.0 microg/mL for three analytes. The intra- and interrun precision (relative standard deviation), calculated from quality control (QC) samples, is less than 13% for three analytes. The accuracy determined from QC samples is between -6.4% and 12%.

摘要

建立了一种简单、灵敏的高效液相色谱（HPLC）方法，用于同时测定犬血浆中泮托拉唑及其两种代谢产物（泮托拉唑砜和泮托拉唑硫醚），并将其应用于比格犬的药代动力学研究。经过蛋白沉淀程序后，样品采用反相HPLC（C18），以乙腈和醋酸铵（pH 6.0）梯度洗脱，流速为1.0 mL/min进行分离，并在290 nm处采用紫外检测进行定量。选用奥美拉唑作为内标。该方法使用0.1 mL血浆等分试样时，泮托拉唑及其两种代谢产物的定量下限为0.025 μg/mL。三种分析物在0.025 - 10.0 μg/mL浓度范围内获得线性校准曲线。根据质量控制（QC）样品计算，三种分析物的批内和批间精密度（相对标准偏差）均小于13%。由QC样品确定的准确度在-6.4%至12%之间。