Abstract
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.
Original language | English |
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Pages (from-to) | 169-175 |
Number of pages | 7 |
Journal | Journal of Pharmaceutical and Biomedical Analysis |
Volume | 173 |
DOIs | |
Publication status | Published - 5 Sept 2019 |
Keywords
- Galunisertb
- LC–MS/MS
- quantification
- assay
- human plasma
- mouse plasma