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

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

Author Suenaga, Eunice Mayumi Autor UNIFESP Google Scholar
Ifa, Demian R. Google Scholar
Cruz, Alessandro Carvalho Google Scholar
Pereira, Renata Google Scholar
Abib, Eduardo Google Scholar
Tominga, Mineko Google Scholar
Nakaie, Clovis Ryuichi Autor UNIFESP Google Scholar
Institution Purdue Univ
Universidade Federal de São Paulo (UNIFESP)
Associacao Paulista Desensolvimento Med SPDM
Scentryphar Clin Res
Universidade Estadual de Campinas (UNICAMP)
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(0-48h) 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.
Keywords Fluoxetine
Internal standard
Liquid chromatography
Mass spectrometry
On-line solid-phase extraction
Language English
Date 2009-02-01
Published in Journal of Separation Science. Weinheim: Wiley-v C H Verlag Gmbh, v. 32, n. 4, p. 637-643, 2009.
ISSN 1615-9306 (Sherpa/Romeo, impact factor)
Publisher Wiley-Blackwell
Extent 637-643
Access rights Closed access
Type Article
Web of Science ID WOS:000264082100019

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