NDLI: Automated determination of venlafaxine in human plasma by on-line SPE-LC-MS/MS. Application to a bioequivalence study.

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Automated determination of venlafaxine in human plasma by on-line SPE-LC-MS/MS. Application to a bioequivalence study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Suenaga, Eunice Mayumi Ifa, Demian R. Cruz, Alessandro Carvalho Pereira, Renata Abib, Eduardo Tominga, Mineko Nakaie, Clovis Ryuichi
Description	Country affiliation: Brazil Author Affiliation: Suenaga EM ( Núcleo de Bioequivalência e Ensaios Clínicos (NuBEC-SPDM), Universidade Federal de São Paulo, UNIFESP, Brazil.)
Abstract	A new automated SPE-LC-ESI-MS/MS method was developed and validated to quantify venlafaxine in human plasma using fluoxetine as an internal standard. The analytes were automatically extracted from plasma by C18 SPE cartridges, separated on a C8 RP column and analyzed by MS in the multiple reaction-monitoring (MRM) mode. The method has a chromatographic run time of 4.0 min and a linear calibration curve over the range of 0.25-200 ng/mL (r >0.997). The between-run precisions, based on the percent RSD for replicate quality controls (0.75; 80, and 200 ng/mL), were < 8.5% for all concentrations. The between-run accuracies, based on the percent relative error, were < 4.0%. This method was successfully employed in a bioequivalence study of two venlafaxine capsule formulations (test formulation from Eurofarma (Brazil) and Efexor XR, reference formulation, from Wyeth-Whitehall, Brazil) in 48 healthy volunteers of both sexes who received a single 150 mg dose of each formulation. More than 3000 samples were analyzed eliminating the analyst's exposure to hazardous organic solvents normally employed in off-line liquid-liquid extractions. The 90% confidence interval (CI) of the individual ratio geometric mean for Test/Reference was 91.6-103.4% for AUC(0-48 h) and 102.2-112.6% for C(max). Since both 90% CI for AUC(0-48 h) and C(max) were included in the 80-125% interval proposed by the US Food and Drug Administration (FDA) and the Brazilian National Health Surveillance Agency (ANVISA), the test formulation was considered bioequivalent to Efexor XR according to both the rate and extent of absorption.
File Format	HTM / HTML
ISSN	16159306
Issue Number	4
Volume Number	32
e-ISSN	16159314
Journal	Journal of Separation Science
Language	English
Publisher	Wiley-VCH
Publisher Date	2009-02-01
Publisher Place	Germany
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Analytical Discipline Chemistry Cyclohexanols Blood Chemistry Solid Phase Extraction Instrumentation Methods Tandem Mass Spectrometry Calibration Humans Molecular Structure Venlafaxine Hydrochloride Journal Article
Content Type	Text
Resource Type	Article
Subject	Analytical Chemistry Filtration and Separation

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