Development and validation of an LC-MS/MS method for the quantification of imatinib and imatinib-d8 in human plasma for the support of an absolute bioavailability microdose trial.
Pharmazie
; 75(4): 136-141, 2020 04 06.
Article
em En
| MEDLINE
| ID: mdl-32295689
ABSTRACT
Here we describe the development and validation of an LC-MS/MS method for the quantification of imatinib and imatinib-d8 in plasma for the support of a clinical absolute bioavailability microdosing trial. The focus lies on the technical aspects to analyse high concentrations of imatinib and low concentrations of imatinib-d8 that are present simultaneously in study samples, using a single sample processing and analytical method. With the validated assay, imatinib and imatinib-d8 can be quantified simultaneously in ranges from 25.0 - 5,000 ng/mL and 0.01 - 2.0 ng/mL, respectively. The method was successfully applied in an imatinib-d8 absolute bioavailability microdosing trial, where a 100 µg imatinib-d8 microdose was intravenously administered to a patient on oral imatinib treatment 400 mg once daily.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Inibidores de Proteínas Quinases
/
Mesilato de Imatinib
Tipo de estudo:
Diagnostic_studies
Limite:
Humans
Idioma:
En
Revista:
Pharmazie
Assunto da revista:
FARMACIA
Ano de publicação:
2020
Tipo de documento:
Article