High-performance liquid chromatography with solid-phase extraction for the quantitative determination of nilotinib in human plasma.
A simple, rapid and sensitive high-performance liquid chromatography (HPLC)-based method with ultraviolet detection was developed for the quantitation of nilotinib, a tyrosine kinase inhibitor, in human plasma. Nilotinib and the internal standard dasatinib were separated using a mobile phase of 0.5% KH(2)PO(4) (pH2.5)-acetonitrile-methanol (55:25:20, v/v/v) on a Capcell Pak MG II column (250 x 4.6 mm) at a flow rate of 0.5 mL/min and optical measurement at 250 nm. Analysis required only 100 microL of plasma and involved a rapid and simple solid-phase extraction with an Oasis HLB cartridge, which gave recoveries from 72 to 78% for nilotinib and from 74 to 76% for dasatinib. The lower limit of quantification for nilotinib was 10 ng/mL. The linear range of this assay was between 10 and 5000 ng/mL (r(2) > 0.9992 for the regression line). Intra- and inter-day coefficients of variation were less than 10.0% and accuracies were within 10.4% over the linear range. Our results indicate that this method is applicable to the monitoring of plasma levels of nilotinib in a clinical setting.
Miura
Masatomo
M
Department of Pharmacy, Akita University Hospital, 1-1-1 Hondo, Akita, Japan. m-miura@hos.akita-u.ac.jp
Takahashi
Naoto
N
Sawada
Ken-ichi
K
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D047428:Protein Kinase Inhibitors / Q000097:blood* / Q000737:chemistry; D011743:Pyrimidines / Q000097:blood* / Q000737:chemistry; D052616:Solid Phase Extraction / Q000379:methods*
D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; C498826:nilotinib