Artigo Acesso aberto Produção Nacional Revisado por pares

Determination of phenobarbital in human plasma by a specific liquid chromatography method: application to a bioequivalence study

2010; Brazilian Chemical Society; Volume: 33; Issue: 1 Linguagem: Inglês

10.1590/s0100-40422010000100023

ISSN

1678-7064

Autores

Sérgio Luiz Dalmora, Maximiliano da Silva Sangoi, Daniele Rubert Nogueira-Librelotto, Felipe Bianchini D’Avila, Ronílson Agnaldo Moreno, Carlos Sverdloff, Rogério Antônio de Oliveira, Ney Carter do Carmo Borges,

Tópico(s)

Pharmaceutical studies and practices

Resumo

A liquid chromatography method was developed and validated for the determination of phenobarbital in human plasma using phenytoin as internal standard. The drugs were extracted from plasma by liquid-liquid extraction and separated isocratically on a C12 analytical column, maintained at 35 ºC, with water:acetonitrile:methanol (58.8:15.2:26, v/v/v) as mobile phase, run at a flow rate of 1.2 mL/min with detection at 205 nm. The method was linear in the range of 0.1-4 μg/mL (r²=0.9999) and demonstrated acceptable results for the precision, accuracy and stability studies. The method was successfully applied for the bioequivalence study of two tablet formulations (test and reference) of phenobarbital 100 mg after single oral dose administration to healthy human volunteers.

Referência(s)