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高效液相色谱法测定人血浆中双氯芬酸及其在土耳其的药代动力学研究中的应用

HPLC method for determination of diclofenac in human plasma and its application to a pharmacokinetic study in Turkey.

作者信息

Yilmaz Bilal, Asci Ali, Palabiyik Saziye Sezin

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Ataturk University, 25240, Erzurum, Turkey.

出版信息

J Chromatogr Sci. 2011;49(6):422-7. doi: 10.1093/chrsci/49.6.422.

Abstract

A simple high-performance liquid chromatography (HPLC) method has been developed for determination of diclofenac in human plasma. The method was validated on Ace C(18) column using UV detection. The mobile phase consisted of 20 mM phosphate buffer (pH 7) containing 0.1% trifluoroacetic acid-acetonitrile (65:35, v/v). Calibration curve was linear between the concentration range of 75-4000 ng/mL. Intra- and inter-day precision values for diclofenac in plasma were less than 3.6, and accuracy (relative error) was better than 5.3%. The limits of detection and quantification of diclofenac were 25 and 75 ng/mL, respectively. Also, this assay was applied to determine the pharmacokinetic parameters of diclofenac in healthy Turkish volunteers who had been given 50 mg diclofenac.

摘要

已开发出一种简单的高效液相色谱(HPLC)方法用于测定人血浆中的双氯芬酸。该方法在Ace C(18)柱上使用紫外检测进行了验证。流动相由含有0.1%三氟乙酸的20 mM磷酸盐缓冲液(pH 7)-乙腈(65:35,v/v)组成。校准曲线在75-4000 ng/mL的浓度范围内呈线性。血浆中双氯芬酸的日内和日间精密度值小于3.6,准确度(相对误差)优于5.3%。双氯芬酸的检测限和定量限分别为25和75 ng/mL。此外,该测定法应用于测定给予50 mg双氯芬酸的健康土耳其志愿者体内双氯芬酸的药代动力学参数。

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