High performance liquid chromatography-electrospray ionization mass spectrometric determination of isosorbide 5-mononitrate in human plasma.
J Chromatogr B Analyt Technol Biomed Life Sci
; 846(1-2): 323-8, 2007 Feb 01.
Article
en En
| MEDLINE
| ID: mdl-16962389
ABSTRACT
A novel, selective and sensitive high performance liquid chromatography-mass spectrometric (HPLC-MS) method has been developed for the determination of isosorbide 5-mononitrate (5-ISMN) in human plasma. With acetaminophen as internal standard, sample pretreatment involved one-step extraction with diethyl ether of 0.5 mL plasma. Analysis was performed on an ACQUITY UPLC BEH C(18) column (100 mm x 2.1mm, 1.7 microm) with mobile phase consisting of acetonitrile-water (2080, v/v). The detection was carried out by means of electrospray ionization mass spectrometry in negative ion mode with selected ion recording (SIR). Standard curves were linear (r(2)> or =0.99) over the concentration range of 1.04-1040 ng/mL. The lower limit of quantification (LLOQ) was 1.04 ng/mL. The intra- and inter-day precisions (RSDs) were less than 8.6% and 13.4%, respectively, and the accuracy (RE) was within +/-0.45%. The method herein described was fully validated and successfully applied to the pharmacokinetic study of 5-ISMN in compound extended-release tablets in 18 healthy male volunteers after oral administration.
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Banco de datos:
MEDLINE
Asunto principal:
Vasodilatadores
/
Cromatografía Líquida de Alta Presión
/
Donantes de Óxido Nítrico
/
Espectrometría de Masa por Ionización de Electrospray
/
Dinitrato de Isosorbide
Tipo de estudio:
Diagnostic_studies
Límite:
Humans
/
Male
Idioma:
En
Año:
2007
Tipo del documento:
Article