Determination of sinomenine sustained-release capsules in healthy Chinese volunteers by liquid chromatography-tandem mass spectrometry.
J Chromatogr B Analyt Technol Biomed Life Sci
; 889-890: 39-43, 2012 Mar 15.
Article
em En
| MEDLINE
| ID: mdl-22342119
ABSTRACT
A sensitive and selective liquid chromatographic tandem mass spectrometric method was developed and validated for the determination of sinomenine in human plasma. Plasma samples were precipitated using methanol with metronidazole as internal standard. Separation was carried out on an Inertsil ODS-3 column using a mixture of 0.2% ammonium acetate solution (A) and methanol (B) as the mobile phase with linear gradient elution as follows 0 min (50%B)â1.5 min (80%B)â4.5 min (80%B)â4.6 min (50%B)â6.0 min (50%B). All mass data were obtained in the positive ion mode, and the fragmentation transitions for the selective multiple reaction monitoring were m/z 330â181 and 172â128 for sinomenine and metronidazole, respectively. The method was fully validated to be accurate and precise with a linear range of 0.5-500 ng/mL and applied to a single- and multiple-dose pharmacokinetics study of sustained-release capsules of sinomenine hydrochloride in 20 healthy Chinese volunteers. After oral administration of a single 60-mg dose, the T(max), C(max), AUC(0-96) and t(1/2) were 7.9±2.0h, 123±22 ng/mL, 3032±682 ng h/mL and 13.4±1.6 h, respectively. After oral administration of the 60 mg capsules twice-daily for 7 consecutive days, these parameters were 4.4±3.6 h, 279±69 ng/mL, 7333±2096 ng h/mL and 15.1±1.3 h, respectively. The AUC and C(max) values after multiple-dose treatment were significantly higher than those after a single-dose treatment (P<0.01), with an accumulation factor of 2.49±0.77.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Cromatografia Líquida
/
Espectrometria de Massas em Tandem
/
Morfinanos
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
Limite:
Adult
/
Humans
/
Male
País/Região como assunto:
Asia
Idioma:
En
Revista:
J Chromatogr B Analyt Technol Biomed Life Sci
Ano de publicação:
2012
Tipo de documento:
Article