Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study

A sensitive and specific method based on liquid chromatography was developed and validated for the determination of phenytoin in human plasma using phenobarbital as internal standard. The drugs were extracted from plasma by liquid-liquid extraction and separated isocratically on a Phenomenex Synerg...

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Detalles Bibliográficos
Autores principales: Dalmora, Sérgio Luiz, Nogueira, Daniele R., Londero, Lidiane F., Santana, Davi P., Gonçalves, Talita M.
Formato: Articulo
Lenguaje:Inglés
Publicado: 2009
Materias:
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/7753
http://www.latamjpharm.org/trabajos/28/2/LAJOP_28_2_1_12_E16P321054.pdf
Aporte de:
id I19-R120-10915-7753
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
bioequivalence; liquid chromatography; liquid-liquid extraction; pharmacokinetics; phenytoin
Medicamento
Cromatografía líquida
spellingShingle Farmacia
bioequivalence; liquid chromatography; liquid-liquid extraction; pharmacokinetics; phenytoin
Medicamento
Cromatografía líquida
Dalmora, Sérgio Luiz
Nogueira, Daniele R.
Londero, Lidiane F.
Santana, Davi P.
Gonçalves, Talita M.
Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study
topic_facet Farmacia
bioequivalence; liquid chromatography; liquid-liquid extraction; pharmacokinetics; phenytoin
Medicamento
Cromatografía líquida
description A sensitive and specific method based on liquid chromatography was developed and validated for the determination of phenytoin in human plasma using phenobarbital as internal standard. The drugs were extracted from plasma by liquid-liquid extraction and separated isocratically on a Phenomenex Synergi MAX-RP C<sub>12</sub> column (150x 4.6 mm i.d.), with water: acetonitrile: methanol(58.8:15.2:26, v/v/v) as mobile phase. Detection was carried out using photodiode array detector set at 205 nm. The chromatographic separation was obtained within 12 min and was linear in the concentration range of 50-2500 ng/mL (r2 = 0.9999). The method was successfully applied for the bioequivalence study of two tablet formulations (test and reference) of phenytoin 100 mg after single oral dose administration to 28 healthy human volunteers. The 90% confidence intervals were calculated for the C<sub>max</sub>, AUC<sub>(0-t)</sub> and AUC<sub>(0-∞)</sub>, giving values between 99.97–118.40% demonstrating the bioequivalence of the two formulations.
format Articulo
Articulo
author Dalmora, Sérgio Luiz
Nogueira, Daniele R.
Londero, Lidiane F.
Santana, Davi P.
Gonçalves, Talita M.
author_facet Dalmora, Sérgio Luiz
Nogueira, Daniele R.
Londero, Lidiane F.
Santana, Davi P.
Gonçalves, Talita M.
author_sort Dalmora, Sérgio Luiz
title Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study
title_short Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study
title_full Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study
title_fullStr Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study
title_full_unstemmed Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study
title_sort determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study
publishDate 2009
url http://sedici.unlp.edu.ar/handle/10915/7753
http://www.latamjpharm.org/trabajos/28/2/LAJOP_28_2_1_12_E16P321054.pdf
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