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Development and validation of an LC-MS/MS method for the determination of pelubiprofen and its active metabolite, trans-alcohol, in human plasma and its application to pharmacokinetic study
- Source :
- Journal of Chromatography B. :62-67
- Publication Year :
- 2015
- Publisher :
- Elsevier BV, 2015.
-
Abstract
- A suitable liquid chromatography tandem mass spectrometry (LC-MS/MS) method is required to determine pelubiprofen and its active metabolite, trans-alcohol (M-D), in human plasma for pharmacokinetic studies of pelubiprofen preparations. After one-step liquid-liquid extraction (LLE) using methyl tert-butyl ether (MTBE), pelubiprofen, M-D, and tolbutamide (the internal standard, IS) were eluted from a Capcellpak C18 ACR column using a gradient mobile phase consisting of 0.1% formic acid in water and acetonitrile at a flow rate 0.35mL/min. The achieved lower limits of quantitation (LLOQ) of pelubiprofen and M-D were both 15ng/mL (S/N>10) and the standard calibration curves for pelubiprofen and M-D were linear (correlation coefficients >0.99) over the studied concentration range (15-2000ng/mL). Intra- and inter-day precisions were within 7.62% for all analytes and the deviation of assay accuracies was within ±13.23%. The developed method was successfully applied to a pharmacokinetic study of pelubiprofen in healthy Korean male volunteers.
- Subjects :
- Adult
Male
Formic acid
Calibration curve
Tolbutamide
Metabolite
Clinical Biochemistry
Biochemistry
Analytical Chemistry
chemistry.chemical_compound
Pharmacokinetics
Limit of Detection
Tandem Mass Spectrometry
Liquid–liquid extraction
Liquid chromatography–mass spectrometry
Humans
Active metabolite
Chromatography
Phenylpropionates
Elution
Reproducibility of Results
Cell Biology
General Medicine
Reference Standards
chemistry
Alcohols
Chromatography, Liquid
Subjects
Details
- ISSN :
- 15700232
- Database :
- OpenAIRE
- Journal :
- Journal of Chromatography B
- Accession number :
- edsair.doi.dedup.....941d6eefcfd45c2bfe00d917c3ad128c