A capillary GC-MS method for analysis of phenytoin and [13C3]-phenytoin from plasma obtained from pulse dose pharmacokinetic studies

J Pharm Biomed Anal. 1998 Sep;17(8):1311-23. doi: 10.1016/s0731-7085(98)00018-1.

Abstract

Stable isotope analogues of phenytoin are useful for pulse dose pharmacokinetic studies in epilepsy patients. A simultaneous assay was developed to quantitate phenytoin (5,5-diphenylhydantoin) and its stable isotope analogue [13C3]-phenytoin (5,5-diphenyl-2,4,5-13C3-hydantoin) from plasma. Quantitation was achieved by GC-MS analysis of liquid/liquid extracted plasma samples, with [2H10]-phenytoin (5,5-di(pentadeuterophenyl)-hydantoin) as an internal standard. The total coefficients of variance (C.V.t) were < 7% for phenytoin (2.5-40 micrograms ml-1) and < 10.3% for [13C3]-phenytoin (0.1-6.0 micrograms ml-1). The accuracy of the assay varied from 87.8-100.1% (phenytoin, 2.5-40 micrograms ml-1) and 89.6-116.3% ([13C3]-phenytoin, 0.02-6.0 micrograms ml-1). The assay was tested under in vivo conditions by administration of a pulse dose of the stable isotope analogue to a single rat dosed to steady-state with fosphenytoin, a phenytoin prodrug. The results of the in vivo experiment demonstrate the usefulness of this assay for future pharmacokinetic studies in special population epilepsy patients.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Animals
  • Anticonvulsants / blood*
  • Anticonvulsants / chemistry
  • Anticonvulsants / pharmacokinetics
  • Gas Chromatography-Mass Spectrometry / methods*
  • Humans
  • Infusions, Intravenous
  • Isotopes
  • Male
  • Molecular Structure
  • Phenytoin / administration & dosage
  • Phenytoin / analogs & derivatives*
  • Phenytoin / blood*
  • Phenytoin / chemistry
  • Phenytoin / metabolism
  • Phenytoin / pharmacokinetics
  • Prodrugs / administration & dosage
  • Prodrugs / metabolism*
  • Rats
  • Rats, Sprague-Dawley
  • Reference Standards

Substances

  • Anticonvulsants
  • Isotopes
  • Prodrugs
  • Phenytoin
  • fosphenytoin