A new high-performance liquid chromatography-tandem mass spectrometry method for the determination of sunitinib and N-desethyl sunitinib in human plasma: Light-induced isomerism overtaking towards therapeutic drug monitoring in clinical routine.

Elena Marangon,Mauro Buzzo,Bianca Posocco,Sara Gagno,Martina Zanchetta,Valentina Iacuzzi,Ariana Soledad Poetto,Michela Guardascione, Luciana Giodini,Giuseppe Toffoli

Journal of Pharmaceutical and Biomedical Analysis（2020）

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摘要

•Development of a new LC–MS/MS method to quantify sunitinib and N-desethyl sunitinib.•2-Method useful for therapeutic drug monitoring and applicable to clinical routine.•Validation according to EMA-FDA guidelines on bioanalytical method validation.•Quantitatively reconversion of E-isomers without the necessity of light protection.•Application of the method to a pharmacokinetic study in patients.

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关键词

Sunitinib and N-desethyl sunitinib,Therapeutic drug monitoring,Z-isomers quantification,LC–MS/MS method,Method validation

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