HPLC assay method for ceftibuten in plasma and its application to pharmacokinetic study

J. W. Bae, C. S. Myung, C. I. Choi, S. M. Moon, C. G. Jang, S. Y. Lee

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

The purpose of this study was to validate a reliable analytical method for pharmacokinetic study of ceftibuten in human plasma by high performance liquid chromatography (HPLC) system with UV detection. Ceftizoxime was used as the internal standard. After plasma sample was precipitated with acetonitrile and dichloromethane, the supernatant was directly injected into the HPLC system. Separation was performed on a Capcell Pak C18 UG120 column (4.6 mm × 250 mm, 5 μm particles) with a mobile phase of acetonitrile/50 mM ammonium acetate (5: 95, v/v) and UV detection at a wavelength of 262 nm. The intra- and inter-day precision expressed as the relative standard deviation was less than 15%. The lower limit of quantification was 0.5 hg/mL of ceftibuten using 0.5 mL of plasma. The calibration curve was linear in concentration range of 0.5-30 μg/mL (r 2 = 0.9998). The mean accuracy was 96-102%. The coefficient of variation (precision) in the intra- and inter-day validation was 0.9-3.9 and 0.9-2.4%, respectively. The pharmacokinetics of ceftibuten was evaluated after a single oral administration of 400 mg to healthy volunteers. The AUC0-9 h, c max, T max, and T 1/2 were 86.6 ± 12.7 μg h/mL, 18.4 ± 1.5 μg/mL, 2.63 ± 0.83 and 2.65 ± 0.41 h, respectively. The method was demonstrated to be highly reproducible and feasible for pharmacokinetic studies of ceftibuten in eight volunteers after oral administration (400 mg as ceftibuten).

Original languageEnglish
Pages (from-to)1261-1265
Number of pages5
JournalJournal of Analytical Chemistry
Volume65
Issue number12
DOIs
StatePublished - Dec 2010

Keywords

  • ceftibuten
  • high performance liquid chromatography
  • plasma

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