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Quantification of Teprenone in Human Plasma by HPLC Coupled to Mass Spectrometry: Application to a Bioequivalence Study

Quantification of Teprenone in Human Plasma by HPLC Coupled to Mass Spectrometry: Application to... A rapid, sensitive, and specific method has been developed for quantification of teprenone (TEP) in human plasma. The analytes were isolated from plasma by liquid–liquid extraction with t-butyl methyl ether. The extracts were analyzed by high-performance liquid chromatography coupled to mass spectrometry (HPLC–MS); gefarnate was used as internal standard (IS). HPLC separation of the analytes was performed on a C18 column with 1:54:45 (v/v) 1% aqueous acetic acid–methanol–acetonitrile as mobile phase; the flow rate was 0.2 mL min−1. The compounds were ionized by atmospheric-pressure chemical ionization (APCI). Calibration plots for TEP were linear in the range 20.0–2000.0 ng mL−1; correlation coefficients were >0.9981. The average extraction efficiency for TEP was >67%, method recovery was >95%, the limit of detection (LOD) was 1.0 ng mL−1, and the intraday and interday coefficients of variation were <7%. This HPLC–MS procedure was used to assess the bioequivalence of TEP tablet and capsule formulations. A single 150-mg dose of each formulation was administered to 18 healthy male volunteers. The study was conducted using an open, randomized, two-period crossover design with a 1-week wash-out interval. Because the 90% CI for C max and the ratios of the AUCs were all within the 80–125% range stipulated by the US Food and Drug Administration, it was concluded that the TEP tablet and capsule formulations were bioequivalent in terms of rate and extent of absorption. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Chromatographia Springer Journals

Quantification of Teprenone in Human Plasma by HPLC Coupled to Mass Spectrometry: Application to a Bioequivalence Study

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References (11)

Publisher
Springer Journals
Copyright
Copyright © 2007 by Friedr. Vieweg & Sohn Verlag/GWV Fachverlage GmbH
Subject
Chemistry; Chromatography; Proteomics; Pharmacy; Laboratory Medicine
ISSN
0009-5893
eISSN
1612-1112
DOI
10.1365/s10337-007-0188-8
Publisher site
See Article on Publisher Site

Abstract

A rapid, sensitive, and specific method has been developed for quantification of teprenone (TEP) in human plasma. The analytes were isolated from plasma by liquid–liquid extraction with t-butyl methyl ether. The extracts were analyzed by high-performance liquid chromatography coupled to mass spectrometry (HPLC–MS); gefarnate was used as internal standard (IS). HPLC separation of the analytes was performed on a C18 column with 1:54:45 (v/v) 1% aqueous acetic acid–methanol–acetonitrile as mobile phase; the flow rate was 0.2 mL min−1. The compounds were ionized by atmospheric-pressure chemical ionization (APCI). Calibration plots for TEP were linear in the range 20.0–2000.0 ng mL−1; correlation coefficients were >0.9981. The average extraction efficiency for TEP was >67%, method recovery was >95%, the limit of detection (LOD) was 1.0 ng mL−1, and the intraday and interday coefficients of variation were <7%. This HPLC–MS procedure was used to assess the bioequivalence of TEP tablet and capsule formulations. A single 150-mg dose of each formulation was administered to 18 healthy male volunteers. The study was conducted using an open, randomized, two-period crossover design with a 1-week wash-out interval. Because the 90% CI for C max and the ratios of the AUCs were all within the 80–125% range stipulated by the US Food and Drug Administration, it was concluded that the TEP tablet and capsule formulations were bioequivalent in terms of rate and extent of absorption.

Journal

ChromatographiaSpringer Journals

Published: Mar 7, 2007

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