Journal
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 193, Issue -, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.jpba.2020.113733
Keywords
Small-molecule kinase inhibitor (SMKI); Ceritinib; Dacomitinib; Lorlatinib; Nintedanib; Ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS)
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Funding
- Pfizer [54332551]
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This article describes the development and validation of a UPLC-MS/MS method for simultaneous analysis of small-molecule kinase inhibitors in human plasma, meeting FDA requirements and demonstrating clinical applicability in patients with lung cancer.
Multiple small-molecule kinase inhibitors with specific molecular targets have recently been developed for the treatment of cancer. This article reports the development and validation of an ultra-performance liquid chromatography/tandem mass spectrometry (UPLC-MS/MS) method to simultaneously analyse the small-molecule kinase inhibitors dacomitinib, ceritinib, lorlatinib, and nintedanib in human plasma. For chromatographic analyte separation, an Acquity UPLC (R) BEH C18 column 1.7 mu m, 50 mm x 2.1 mm was used with a binary gradient of pure water/formic acid/ammonium formate (100:0.1:0.02, v/v/v) and methanol/formic acid (100:0.1, v/v). Calibration curves for all small-molecule kinase inhibitors were 5.00-500 ng/mL. Validation of this method met all requirements of the Food and Drug administration. Additionally, clinical applicability was demonstrated by quantification of multiple samples from a pharmacokinetic study in patients with lung cancer. (C) 2020 The Author(s). Published by Elsevier B.V.
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