Dilger C, Salama Z, Jaeger H
Analytical Research Centre, LAB GmbH, Neu-Ulm, Fed. Rep. of Germany.
Arzneimittelforschung. 1988 Oct;38(10):1525-8.
An improved high performance liquid chromatographic (HPLC) assay for the quantitative determination of trans-doxepin (I) and desmethyldoxepin (II) in body fluids is presented. This HPLC assay, employing a UV-detector and perazine (III) as an internal standard, provides a very sensitive and selective determination in the low ng/ml range. The lower limit of quantification was 0.426 ng/ml (I) and 0.50 ng/ml (II); respectively. The calibration curve was linear in the measured range of 0.426-34.08 ng/ml (I) and 0.50-40 ng/ml (II). In combination with the excellent precision and accuracy data (c.v. values typically lower than 5%) and a recovery exceeding 90% for both compounds, the method is well suited for quantitative determinations of plasma samples generated during clinical studies, eg. evaluating the pharmacokinetics and/or bioavailability/bioequivalence as well as evaluations of clinical response.
本文介绍了一种改进的高效液相色谱（HPLC）分析法，用于定量测定体液中的反式多塞平（I）和去甲基多塞平（II）。这种HPLC分析法采用紫外检测器，以哌嗪（III）作为内标，在低纳克/毫升范围内提供了非常灵敏和选择性的测定。定量下限分别为0.426纳克/毫升（I）和0.50纳克/毫升（II）。校准曲线在0.426 - 34.08纳克/毫升（I）和0.50 - 40纳克/毫升（II）的测量范围内呈线性。结合出色的精密度和准确度数据（变异系数值通常低于5%）以及两种化合物超过90%的回收率，该方法非常适合临床研究中血浆样本的定量测定，例如评估药代动力学和/或生物利用度/生物等效性以及临床反应评估。
