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Determination of fexofenadine enantiomers in human plasma with high-performance liquid chromatography.
J Pharm Biomed Anal. 2007 Jan 17; 43(2):741-5.JP

Abstract

A simple and sensitive high-performance liquid chromatography (HPLC) method was developed as an assay for fexofenadine enantiomers in human plasma. Fexofenadine enantiomers were separated using a mobile phase of 0.5% KH(2)PO(4)-acetonitrile (65:35, v/v) on a Chiral CD-Ph column at a flow rate of 0.5 ml/min and measurement at 220 nm. Analysis required 400 microl of plasma and involved solid-phase extraction with an Oasis HLB cartridge, which gave recoveries for both enantiomers from 67.4 to 71.8%. The lower limit of quantification was 25 ng/ml for (R)- and (S)-fexofenadine. The linear range of this assay was between 25 and 625 ng/ml (regression line r(2)>0.993). Inter- and intra-day coefficients of variation were less than 13.6% and accuracies were within 8.8% over the linear range for both analytes. This method can be applied effectively to measure fexofenadine enantiomer concentrations in clinical samples.

Authors+Show Affiliations

Miura M
Department of Pharmacy, Akita University Hospital, 1-1-1 Hondo, Akita 010-8543, Japan. m-miura@hos.akita-u.ac.jp
Uno T
No affiliation info available
Tateishi T
No affiliation info available
Suzuki T
No affiliation info available

MeSH

AcetonitrilesCalibrationChromatography, High Pressure LiquidDrug StabilityHistamine H1 Antagonists, Non-SedatingHumansLinear ModelsMolecular StructurePhosphatesPotassium CompoundsReference ValuesReproducibility of ResultsSensitivity and SpecificitySolventsSpectrophotometry, UltravioletStereoisomerismTerfenadine

Pub Type(s)

Clinical Trial
Journal Article
Validation Study

Language

eng

PubMed ID

16934428

Citation

Miura, Masatomo, et al. "Determination of Fexofenadine Enantiomers in Human Plasma With High-performance Liquid Chromatography." Journal of Pharmaceutical and Biomedical Analysis, vol. 43, no. 2, 2007, pp. 741-5.
Miura M, Uno T, Tateishi T, et al. Determination of fexofenadine enantiomers in human plasma with high-performance liquid chromatography. J Pharm Biomed Anal. 2007;43(2):741-5.
Miura, M., Uno, T., Tateishi, T., & Suzuki, T. (2007). Determination of fexofenadine enantiomers in human plasma with high-performance liquid chromatography. Journal of Pharmaceutical and Biomedical Analysis, 43(2), 741-5.
Miura M, et al. Determination of Fexofenadine Enantiomers in Human Plasma With High-performance Liquid Chromatography. J Pharm Biomed Anal. 2007 Jan 17;43(2):741-5. PubMed PMID: 16934428.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Determination of fexofenadine enantiomers in human plasma with high-performance liquid chromatography. AU - Miura,Masatomo, AU - Uno,Tsukasa, AU - Tateishi,Tomonori, AU - Suzuki,Toshio, Y1 - 2006/08/24/ PY - 2006/06/01/received PY - 2006/07/13/revised PY - 2006/07/18/accepted PY - 2006/8/29/pubmed PY - 2007/7/10/medline PY - 2006/8/29/entrez SP - 741 EP - 5 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 43 IS - 2 N2 - A simple and sensitive high-performance liquid chromatography (HPLC) method was developed as an assay for fexofenadine enantiomers in human plasma. Fexofenadine enantiomers were separated using a mobile phase of 0.5% KH(2)PO(4)-acetonitrile (65:35, v/v) on a Chiral CD-Ph column at a flow rate of 0.5 ml/min and measurement at 220 nm. Analysis required 400 microl of plasma and involved solid-phase extraction with an Oasis HLB cartridge, which gave recoveries for both enantiomers from 67.4 to 71.8%. The lower limit of quantification was 25 ng/ml for (R)- and (S)-fexofenadine. The linear range of this assay was between 25 and 625 ng/ml (regression line r(2)>0.993). Inter- and intra-day coefficients of variation were less than 13.6% and accuracies were within 8.8% over the linear range for both analytes. This method can be applied effectively to measure fexofenadine enantiomer concentrations in clinical samples. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/16934428/Determination_of_fexofenadine_enantiomers_in_human_plasma_with_high_performance_liquid_chromatography_ DB - PRIME DP - Unbound Medicine ER -