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Development and validation of a novel LC-MS/MS method for simultaneous quantitative determination of tyrosine kinase inhibi ... 1 1 Introduction 1 2 Experimental 2 2.1 Chemicals and reagents 2 2.2 Working solutions of calibration standard (CS), quality control (QC), and internal standard (IS) 2 2.3 Sample preparation 2 2.4 LC-MS/MS system 2 2.4.1 Chromatographic conditions 2 2.4.2 Mass spectrometric conditions 2 2.5 Method validation 2 2.5.1 Specificity and selectivity 2 2.5.2 Calibration curves and LLOQ 2 2.5.3 Accuracy and precision 2 2.5.4 Extraction recovery and matrix effect 2 2.5.5 Stability 2 2.5.6 Dilution integrity 3 2.5.7 Carry-over 3 2.5.8 Cross validations 3 2.6 Clinical applicability 3 3 Results 3 3.1 Method development 3 3.1.1 Optimization of mass spectrometry 3 3.1.2 Optimization of liquid chromatography 3 3.1.3 Sample preparation 3 3.2 Method validation 3 3.2.1 Specificity and selectivity 3 3.2.2 Linearity and LLOQ 3 3.2.3 Accuracy and precision 5 3.2.4 Extraction recovery and matrix effect 5 3.2.5 Stability 5 3.2.6 Dilution integrity 5 3.2.7 Carry-over 6 3.2.8 Cross validations 6 3.3 Clinical applicability 6 4 Discussion 7 5 Conclusions 7 CRediT authorship contribu

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nonfiction