Bioanalytical technique for determination of tasimelteon in human plasma by LC-MS/MS and its application to pharmacokinetic study in humans.
Biomed Chromatogr
; 33(3): e4431, 2019 Mar.
Article
em En
| MEDLINE
| ID: mdl-30412929
ABSTRACT
A highly sensitive, specific and rapid liquid chromatography-tandem mass spectrometry technique for the quantification of tasimelteon in human plasma has been developed and validated using tasimelteon-d5 as internal standard. Liquid-liquid extraction technique with ethyl acetate was used for extraction of tasimelteon from the plasma. The chromatographic separation was achieved on an Agilent Zorbax, Eclipse, C18 (4.6 × 50 mm, 5 µm) column using a mobile phase of acetonitrile and 0.02% formic acid buffer (8515, v/v) with a flow rate of 0.5 mL/min. A detailed method validation was performed as per the United States Food and Drug Administration guidelines. The linear calibration curve was obtained over the concentration range 0.30-299 ng/mL. The API-4000 liquid chromatography-tandem mass spectrometry was operated under multiple reaction monitoring mode during analysis. The validated method was successfully applied to estimate plasma concentration of tasimelteon after oral administration of a single dose of a 20 mg capsule in healthy volunteers under fasting conditions. The maximum concentration of the drug achieved in the plasma was 314 ± 147 ng/mL and the time at which this concentration was attained was 0.54 ± 0.22 h.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Benzofuranos
/
Cromatografia Líquida
/
Ciclopropanos
/
Espectrometria de Massas em Tandem
Tipo de estudo:
Prognostic_studies
Limite:
Adult
/
Humans
/
Male
Idioma:
En
Revista:
Biomed Chromatogr
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Índia