Development and validation of a liquid chromatography-tandem mass spectrometry assay for nine oral anticancer drugs in human plasma.
J Pharm Biomed Anal
; 174: 561-566, 2019 Sep 10.
Article
em En
| MEDLINE
| ID: mdl-31255856
ABSTRACT
A liquid chromatography-tandem mass spectrometry assay was developed and validated for the nine oral anticancer agents alectinib, cobimetinib, lenvatinib, nintedanib, osimertinib, palbociclib, ribociclib, vismodegib and vorinostat in order to support therapeutic drug monitoring (TDM). The assay was based on reversed-phase chromatography coupled with tandem mass spectrometry operating in the positive ion mode. The assay was validated based on the guidelines on bioanalytical methods by the US Food and Drug Administration and European Medicines Agency. The method was validated over a linear range of 10-200â¯ng/mL for alectinib, lenvatinib, nintedanib and vismodegib; 50-1000â¯ng/mL for cobimetinib and palbociclib; 100-2000â¯ng/mL for osimertinib; 5.00-100â¯ng/mL for ribociclib; 25-500â¯ng/mL for vorinostat. Intra-assay and inter-assay bias was within ±20% for all analytes at the lower limit of quantification and within ±15% at remaining concentrations. Stability experiments showed that osimertinib is unstable in the biomatrix and should be shipped on dry-ice and stored at -20⯰C until analysis. All other compounds were stable in the biomatrix. The described TDM method was successfully validated and applied for TDM in patients treated with these KIs.
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Texto completo:
1
Coleções:
01-internacional
Temas:
Geral
Base de dados:
MEDLINE
Assunto principal:
Cromatografia Líquida
/
Espectrometria de Massas em Tandem
/
Antineoplásicos
Tipo de estudo:
Guideline
Limite:
Humans
Idioma:
En
Revista:
J Pharm Biomed Anal
Ano de publicação:
2019
Tipo de documento:
Article