DETERMINATION OF PHENOBARBITAL IN HUMAN PLASMA BY A SPECIFIC LIQUID CHROMATOGRAPHY METHOD: APPLICATION TO A BIOEQUIVALENCE STUDY

作者:Dalmora Sergio Luiz*; Sangoi Maximiliano da Silva; Nogueira Daniele Rubert; D'Avila Felipe Bianchini; Moreno Ronilson Agnaldo; Sverdloff Carlos Eduardo; de Oliveira Rogerio Antonio; Borges Ney Carter
来源:Quimica Nova, 2010, 33(1): 124-129.
DOI:10.1590/S0100-40422010000100023

摘要

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 C(12) analytical column, maintained at 35 degrees C, 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 mu g/mL (r(2)=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.

  • 出版日期2010