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High-performance liquid chromatographic assay for the determination of nilotinib in human plasma.

Misato Yuki, Yuji Yamakawa, Takashi Uchida, Takeru Nambu, Tatsuya Kawaguchi, Akinobu Hamada, Hideyuki Saito

Department of Clinical Pharmaceutical Sciences, School of Pharmaceutical Sciences, Kumamoto University, 5–1 Oehonmachi, Kumamoto 862–0973, Japan.

Journal Article: Biological & Pharmaceutical Bulletin (impact factor: 1.81). 01/2011; 34(7):1126-8.

Abstract

A precise and convenient high-performance liquid chromatography (HPLC) method has been established to assay nilotinib in human plasma. Chromatographic separation of nilotinib was performed on a LiChrosphere(®)100 RP-18(e) column (250 mm×4.0 mm, 5 µm) using a mixture of acetonitrile and 0.01 M phosphate buffer (pH 3.0) (42 : 58, v/v) under isocratic conditions at a flow rate of 1.0 ml/min with ultraviolet (UV) detection at 266 nm. The calibration curve showed linearity at concentrations between 250 ng/ml and 5000 ng/ml (r(2)>0.999). The mean±S.D. absolute recovery of nilotinib from plasma was 99.2±3.3%. The coefficients of variation of both intra- and inter-day precision were below 9.1%. These results indicate that this new HPLC-based quantification may be useful for therapeutic drug monitoring of nilotinib to help manage treatment in patients with chronic myeloid leukemia in clinical practice.

Source: PubMed

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Keywords

assay nilotinib
 
calibration curve
 
Chromatographic separation
 
chronic myeloid leukemia
 
concentrations
 
convenient high-performance liquid chromatography
 
flow rate
 
human plasma
 
inter-day precision
 
M phosphate buffer
 
mean±S.D. absolute recovery
 
new HPLC-based quantification
 
nilotinib
 
plasma
 
therapeutic drug monitoring
 
UV