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

Abstract

Recebido em 17/2/09; aceito em 22/6/09; publicado na web em 25/11/09 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 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 (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.

Determination of levodopa in human plasma by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS): application to a bioequivalence study

“…[10][11][12] Recently, the literature reports a large number of studies performed using high performance liquid chromatography coupled to tandem mass spectrometry (HPLC-MS/MS) for the determination of drugs in biological fluids. [13][14][15] However, few methods for determining LVP in plasma using HPLC-MS/MS have been developed and validated. 12 Therefore, further studies are necessary to further improve quantitation techniques allowing the measurement of low concentrations of LVP and 3OMD in human plasma with high selectivity and sensitivity.…”

Phenobarbital loaded microemulsion: development, kinetic release and quality control

“…It is one of the most common serious neurological disorders worldwide, which can be successfully controlled with one single antiepileptic. Uncontrolled seizures may result in injuries, embarrassment, anxiety, unpredictability, and occasionally may induce death (Dalmora et al, 2010).…”

“…It is widely used as an antiepileptic drug for it is complete and very effective drug and has advantages such as low cost, broad spectrum of action and ease of use (Dalmora et al, 2010). It is a centenarian drug and is still the best costbenefit pharmacological treatment for epilepsy, especially in developing countries (Brodie, Kwan, 2012).…”

“…In the literature, several PB quantification methods are described, such as titration (ANVISA, 2010), spectrophotometry (Boeris, Luco, Olsina, 2000), high performance liquid chromatography (HPLC) (Dalmora et al, 2010;ANVISA, 2010), and immunoassays (Spiehler et al, 1976;Pastore, Ofuchi, Nishiyama, 2007). Several pharmaceutical formulations were described, such as oral solution (Yska et al, 2000) and tablets (Goicoechea, Olivieri, 1998).…”

Determinação quantitativa de fenobarbital em plasma por cromatografia líquida de alta eficiência

“…É utilizado principalmente no controle de convulsões dos tipos tônico-clônicas e parcial simples, em concentrações que produzem sedação mínima. Atua como depressor não seletivo do sistema nervoso central (SNC) (DALMORA et al, 2010). Apresenta uma margem terapêutica estreita de 10 a 40 µg.mL -1 e o desenvolvimento de tolerância resulta na ingestão de doses muito maiores que a dose terapêutica, e dados na literatura mostram que há toxicidade em concentração sérica acima de 30 µg.mL -1 (PASTORE et al, 2007).…”