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Liquid chromatography-tandem mass spectrometric assay for the quantification of galunisertib in human plasma and the application in a pre-clinical study.
- Source :
-
Journal of Pharmaceutical & Biomedical Analysis . Sep2019, Vol. 173, p169-175. 7p. - Publication Year :
- 2019
-
Abstract
- • First reported quantitative assay for the determination of galunisertib in human plasma. • Fast and elegant HPLC-MS/MS method for quantification of galunisertib in human plasma. • Application of a simple chromatographic method for quantification of galunisertib in small volumes of mouse plasma. Galunisertib is an anti-cancer drug currently evaluated in phase I and II clinical trials. This study describes the development and validation of a bioanalytical assay to quantify galunisertib in human plasma using HPLC-MS/MS. Stable isotope labelled galunisertib was added as internal standard and the analyte and internal standard were extracted from the matrix by protein precipitation using acetonitrile-methanol (50:50, v/v). Final extracts were injected onto a C18 column, gradient elution was applied for chromatographic separation and detection was performed using a triple quadrupole mass spectrometer operating in the positive ion mode. The assay was linear over the range 0.05–10 ng/mL, with acceptable accuracy (bias ranging from −6.1 to 3.1%) and precision (below 5.7% C.V.) values. The applicability of the assay was demonstrated in a pharmacokinetic experiment in mice. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 07317085
- Volume :
- 173
- Database :
- Academic Search Index
- Journal :
- Journal of Pharmaceutical & Biomedical Analysis
- Publication Type :
- Academic Journal
- Accession number :
- 136824261
- Full Text :
- https://doi.org/10.1016/j.jpba.2019.05.037