采用1-氟-2,4-二硝基苯柱前衍生化法测定人血浆中加巴喷丁的高效液相色谱验证方法及其在药代动力学研究中的应用。

Validated HPLC method for the determination of gabapentin in human plasma using pre-column derivatization with 1-fluoro-2,4-dinitrobenzene and its application to a pharmacokinetic study.

作者信息

Jalalizadeh Hassan, Souri Effat, Tehrani Maliheh Barazandeh, Jahangiri Alireza

机构信息

Department of Medicinal Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran 14155-6451, Iran.

出版信息

J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Jul 1;854(1-2):43-7. doi: 10.1016/j.jchromb.2007.03.039. Epub 2007 Apr 5.

DOI:10.1016/j.jchromb.2007.03.039

PMID:17517538

Abstract

A rapid, sensitive and accurate high-performance liquid chromatographic method with UV detection was developed and validated for the quantification of gabapentin in human plasma. Gabapentin was quantified using pre-column derivatization with 1-fluoro-2,4-dinitrobenzene following protein precipitation of plasma with acetonitrile. Amlodipine was used as internal standard. The chromatographic separation was carried out on a Nova-Pak C(18) column using a mixture of 50 mM NaH(2)PO(4) (pH=2.5)-acetonitrile (30:70, v/v) as mobile phase with UV detection at 360 nm. The flow rate was set at 1.5 ml/min. The method was linear over the range of 0.05-5 microg/ml of gabapentin in plasma (r(2)>0.999). The within-day and between-day precision values were in the range of 2-5%. The limit of quantification of the method was 0.05 microg/ml. The method was successfully used to study the pharmacokinetics of gabapentin in healthy volunteers.

摘要

建立了一种采用紫外检测的快速、灵敏且准确的高效液相色谱法，并对其进行验证，用于定量测定人血浆中的加巴喷丁。血浆经乙腈沉淀蛋白后，加巴喷丁采用1-氟-2,4-二硝基苯进行柱前衍生化定量。氨氯地平用作内标。色谱分离在Nova-Pak C(18)柱上进行，以50 mM NaH(2)PO(4)（pH = 2.5）-乙腈（30:70，v/v）的混合物作为流动相，在360 nm处进行紫外检测。流速设定为1.5 ml/min。该方法在血浆中加巴喷丁浓度为0.05 - 5 μg/ml范围内呈线性（r(2)>0.999）。日内和日间精密度值在2 - 5%范围内。该方法的定量限为0.05 μg/ml。该方法成功用于研究健康志愿者体内加巴喷丁的药代动力学。