Validated LC-MS/MS assay for the quantitative determination of vardenafil in human plasma and its application to a pharmacokinetic study

Lake, Simon T., Altman, Phillip M., Vaisman, Jack and Addison, Russell S. (2010) Validated LC-MS/MS assay for the quantitative determination of vardenafil in human plasma and its application to a pharmacokinetic study. Biomedical Chromatography, 24 8: 846-851. doi:10.1002/bmc.1375


Author Lake, Simon T.
Altman, Phillip M.
Vaisman, Jack
Addison, Russell S.
Title Validated LC-MS/MS assay for the quantitative determination of vardenafil in human plasma and its application to a pharmacokinetic study
Journal name Biomedical Chromatography   Check publisher's open access policy
ISSN 1099-0801
0269-3879
Publication date 2010-08-01
Year available 2009
Sub-type Article (original research)
DOI 10.1002/bmc.1375
Volume 24
Issue 8
Start page 846
End page 851
Total pages 6
Editor C. K. Lim
Place of publication United Kingdom
Publisher John Wiley & Sons
Collection year 2010
Language eng
Subject C1
920299 Health and Support Services not elsewhere classified
111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract A sensitive high-performance liquid chromatography-tandem mass spectrometric (HPLC-MS/MS) assay has been developed for the quantitative analysis of vardenafil in human plasma. Vardenafil and the internal standard, alprazolam, were extracted from 0.2 mL aliquots of alkalinized plasma by a single solvent extraction into hexane : dichloromethane. Reversed-phase chromatographic separation was affected by gradient elution with mobile phases consisting of 10 mM ammonium formate pH 7.0 (solvent A) and methanol (100%, solvent B), delivered at a flow rate of 0.4 mL/min. The analytes were detected by using an electrospray ion source on a 4000 QTrap triple quadrupole mass spectrometer operating in positive ionization mode. The mass transitions were m/z 489.3 312.2 for vardenafil and m/z 309.2 281.0 for alprazolam. The assay was linear over the concentration range of 0.2-100 ng/mL, with correlation coefficients 0.995. The intra- and inter-day precision was less than 5.4% in terms of relative standard deviation and the accuracy was within 12.7% in terms of relative error. The lower limit of quantitation was set at 0.2 ng/mL. The high sensitivity and acceptable performance of the assay allowed its application to the analysis of plasma samples obtained following the oral administration of vardenafil to healthy male volunteers in a pharmacokinetic study. Copyright © 2009 John Wiley & Sons, Ltd.
Keyword Vardenafil
Plasma
mass Spectrometry
LC-MS/MS
Assay validation
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Article first published online: 23 DEC 2009

 
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Created: Thu, 15 Apr 2010, 20:51:54 EST by Barb Clyde on behalf of Centre for Integrated Preclinical Drug Development