Determination of finasteride in human plasma by HPLC-MS / 药学学报
Acta Pharmaceutica Sinica
;
(12): 455-457, 2003.
Artigo
em Chinês
| WPRIM
| ID: wpr-251062
ABSTRACT
<p><b>AIM</b>To develop an HPLC-MS assay for determination of finasteride in human plasma and to investigate the bioequivalence in healthy volunteers.</p><p><b>METHODS</b>After alkalization with sodium hydroxide, plasma was extracted with ethyl acetate and separated using a C18 column with a mobile phase of methanol-water (8515). LC-ESI-MS was performed in the selected ion monitoring (SIM) mode using target ions at m/z 395 for finasteride and m/z 407 for the IS. The fragmentor voltage was 120 V. A randomized crossover design was performed in 20 healthy volunteers. In the two study periods, a single 10 mg dose of each tablet was administered to each volunteer.</p><p><b>RESULTS</b>Calibration curves were linear over the range 1-200 micrograms.L-1 (r = 0.9986). The limit of determination for finasteride in plasma was 0.05 microgram.L-1. The recovery of finasteride from plasma was in the range of 85.9%-98.7%. The results of variance analysis and two one-side t-test showed that there was no significant difference between the two formulations in the AUC and Cmax.</p><p><b>CONCLUSION</b>The assay was proved to be sensitive, accurate and convenient. The two formulations were bioequivalent.</p>
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Sangue
/
Farmacocinética
/
Equivalência Terapêutica
/
Distribuição Aleatória
/
Cromatografia Líquida de Alta Pressão
/
Finasterida
/
Estudos Cross-Over
/
Área Sob a Curva
/
Espectrometria de Massas por Ionização por Electrospray
/
Inibidores Enzimáticos
Tipo de estudo:
Ensaio Clínico Controlado
/
Estudo prognóstico
Limite:
Adulto
/
Humanos
/
Masculino
Idioma:
Chinês
Revista:
Acta Pharmaceutica Sinica
Ano de publicação:
2003
Tipo de documento:
Artigo
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