Microdose clinical trial: Quantitative determination of fexofenadine in human plasma using liquid chromatography/electrospray ionization tandem mass spectrometry

A sample treatment procedure and high-sensitive liquid chromatography/electrospray ionization tandem mass spectrometry (LC/ESI-MS/MS) method for quantitative determination of fexofenadine in human plasma was developed for a microdose clinical trial with a cold drug, i.e., a non-radioisotope-labeled...

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Bibliographic Details
Published in:	Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Vol. 858; no. 1; pp. 118 - 128
Main Authors:	Yamane, Naoe, Tozuka, Zenzaburou, Sugiyama, Yuichi, Tanimoto, Toshiko, Yamazaki, Akira, Kumagai, Yuji
Format:	Journal Article
Language:	English
Published:	Amsterdam Elsevier B.V 15-10-2007 Elsevier Science
Subjects:	Analysis Analytical, structural and metabolic biochemistry Anti-Allergic Agents - administration & dosage Anti-Allergic Agents - blood Anti-Allergic Agents - pharmacokinetics Biological and medical sciences Calibration Chromatography, Liquid - methods Electrospray ionization Fexofenadine Fundamental and applied biological sciences. Psychology General pharmacology Humans Medical sciences Microdosing Molecular Structure Pharmacology. Drug treatments Randomized Controlled Trials as Topic Reproducibility of Results Solid Phase Extraction Spectrometry, Mass, Electrospray Ionization - methods Tandem mass spectrometry Tandem Mass Spectrometry - methods Terfenadine - administration & dosage Terfenadine - analogs & derivatives Terfenadine - blood Terfenadine - pharmacokinetics Validation Validation Tandem mass spectrometry Fexofenadine Electrospray ionization Microdosing Human Biological fluid Antihistaminic Electrospray Blood plasma Mass spectrometry MS/MS Clinical trial Antagonist H1 Histamine receptor Quantitative analysis
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Summary:	A sample treatment procedure and high-sensitive liquid chromatography/electrospray ionization tandem mass spectrometry (LC/ESI-MS/MS) method for quantitative determination of fexofenadine in human plasma was developed for a microdose clinical trial with a cold drug, i.e., a non-radioisotope-labeled drug. Fexofenadine and terfenadine, as internal standard, were extracted from plasma samples using a 96-well solid-phase extraction plate (Oasis HLB). Quantitation was performed on an ACQUITY UPLC system and an API 5000 mass spectrometer by multiple reaction monitoring. Chromatographic separation was achieved on an XBridge C18 column (100 mm × 2.1 mm i.d., particle size 3.5 μm) using acetonitrile/2 mM ammonium acetate (91:9, v/v) as the mobile phase at a flow rate of 0.6 ml/min. The analytical method was validated in accordance with the FDA guideline for validation of bioanalytical methods. The calibration curve was linear in the range of 10–1000 pg/ml using 200 μl of plasma. Analytical method validation for the clinical dose, for which the calibration curve was linear in the range of 1–500 ng/ml using 20 μl of plasma, was also conducted. Each method was successfully applied for making determinations in plasma using LC/ESI-MS/MS after administration of a microdose (100 μg solution) and a clinical dose (60 mg dose) in eight healthy volunteers.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1570-0232 1873-376X
DOI:	10.1016/j.jchromb.2007.08.011