Journal
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
Volume 877, Issue 20-21, Pages 1894-1900Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jchromb.2009.05.034
Keywords
Nilotinib; AMN-107; LC-MS; Mass spectrometry; Chronic myeloid leukemia
Funding
- Novartis Pharmaceuticals [NCI 2P30 CA47904]
- NIH/NCRR/GCRC [5M01RR00056]
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Nilotinib (AMN-107, Tasigna (TM)) is a small-molecule inhibitor of BCR/ABL, approved for chronic myelogenous leukemia. We developed and validated, according to FDA-guidelines, an LC-MS assay for sensitive, accurate and precise quantitation of nilotinib in 0.2 mL human plasma or serum After ace. tonitrile protein precipitation, separation is achieved with a hydro-Synergi column and a 0.1% formic acid in methanol/water-gradient. Detection uses electrospray, positive-mode ionization mass spectrometry. Between 5 (LLOQ) and 5000 ng/mL, accuracy (92.1-109.5%), intra-assay precision (2.5-7.8%), and inter-assay precision (0-5.6%)) were within FDA limits. We demonstrated the suitability of this assay by quantitating plasma concentrations of nilotinib in a healthy volunteer after oral administration of 400 mg nilotinib. (C) 2009 Elsevier B.V. All rights reserved.
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