Determination of nimodipine in plasma by HPLC-MS/MS and pharmacokinetic application

Author:

Nascimento Demétrius Fernandes do1,Moraes Manoel Odorico de1,Bezerra Fernando Antônio Frota1,Pontes Andréa Vieira1,Uchoa Célia Regina Amaral1,Moraes Renata Amaral de1,Leite Ismenia Osório1,Santana Gilmara Silva de Melo1,Santana Ana Paula Macedo1,Leite Ana Lourdes Almeida e Silva1,Pedrazzoli Júnior José1,Moraes Maria Elisabete Amaral de1

Affiliation:

1. Federal University of Ceará

Abstract

To develop and validate a rapid, specific and highly sensitive method to quantify nimodipine in human plasma using dibucaine as the internal standard (IS). The analyte and IS were extracted from plasma samples by liquid-liquid extraction using hexane-ethyl acetate (1:1 v/v). The chromatographic separation was performed on a Varian® Polaris C18 analytical column (3 μm, 50 x 2.0 mm) and pre-column SecurityguardTM C18 (4.0 x 3.0 mm) with a mobile phase of Acetonitrile-Ammonium acetate 0.02 ml/L (80:20v/v). The method had a chromatographic run time of 4.5 min and linear calibration curve over the range of 0.1- 40 ng/mL (r > 0.9938). The limit of quantification was 100 pg/mL. Acceptable precision and accuracy were obtained for concentrations over the standard curve ranges. This validated method was successfully applied in determining the pharmacokinetic profile of nimodipine tablets of 30 mg administered to 24 healthy volunteers. The proposed method of analysis provided a sensitive and specific assay for nimodipine determination in human plasma. The time for the determination of one plasma sample was 4.5 min. This method is suitable for the analysis of nimodipine in human plasma samples collected for pharmacokinetic, bioavailability or bioequivalence studies in humans.

Publisher

FapUNIFESP (SciELO)

Subject

General Pharmacology, Toxicology and Pharmaceutics

Reference41 articles.

1. Manual de boas práticas em biodisponibilidade: bioequivalência. Gerência-Geral de Inspeção e Controle de Medicamentos e Produtos,2002

2. Farmacotécnica: Formas farmacêuticas & sistemas de liberação de fármacos;ANSEL H.C.,2000

3. High-performance liquid chromatography with ultraviolet and fluorimetric detection for the simultaneous determination of tacrine, nimodipine, and their respective metabolites in the plasma of patients with Alzheimer disease;AYMARD G.;Ther. Drug Monit.,1998

4. Nimodipine: Drug pharmacokinetics and plasma adenosine levels in patients affected by cerebral ischemia;BLARDI P.;Clin. Pharmacol. Ther.,2002

5. Resolução Nº 899, de 29 de maio de 2003: Guia para validação de métodos analíticos e bioanalíticos. Agência Nacional de Vigilância Sanitária (ANVISA);Diário oficial da República Federativa do Brasil, Poder executivo,2003

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3