文章基本信息

标题：High-Performance Liquid Chromatographic Assay for the Determination of Nilotinib in Human Plasma
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作者：Misato Yuki ; Yuji Yamakawa ; Takashi Uchida 等
期刊名称：Biological and Pharmaceutical Bulletin
印刷版ISSN：0918-6158
电子版ISSN：1347-5215
出版年度：2011
卷号：34
期号：7
页码：1126-1128
DOI：10.1248/bpb.34.1126
出版社：The Pharmaceutical Society of Japan
摘要：A precise and convenient high-performance liquid chromatography (HPLC) method has been estab-lished 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.
关键词：nilotinib;HPLC;therapeutic drug monitoring;pharmacokinetics;chronic myeloid leukemia