Liquid chromatography-electrospray tandem mass spectrometric assay suitable for quantitation of YM155, a novel small-molecule survivin suppressant, in dog plasma

被引:9
作者
Minematsu, Tsuyoshi [1 ]
Felder, Laurie [2 ]
Oppeneer, Todd [2 ]
Sakazume, Masashi [3 ]
Oikawa, Keishi [4 ]
Hashimoto, Tadashi [1 ]
Usui, Takashi [1 ]
Kamimura, Hidetaka [1 ]
机构
[1] Astellas Pharma Inc, Drug Metab Res Labs, Itabashi Ku, Tokyo 1748511, Japan
[2] Covance Labs Inc, Madison, WI USA
[3] Astellas Res Technol Co Ltd, Tokyo, Japan
[4] Astellas Pharma Inc, Clin Pharmacol, Tokyo, Japan
关键词
YM155; bioanalytical method; LC-MS/MS; validation; pharmacokinetics; dog plasma;
D O I
10.1002/bmc.996
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
This paper describes a sensitive and selective liquid chromatography with tandem mass spectrometry (LC-MS/MS) method for determination of the novel survivin suppressant YM155, 1-(2-methoxyethyl)-2-methyl-4,9-dioxo-3-(pyrazin-2-ylmethyl)-4,9-dihydro-1H-naphtho[2,3-d]imidazolium, which is developed for the treatment of solid tumors. This method uses a liquid-liquid extraction from 0.25 mL of dog plasma. LC separation was carried out on a Genesis Silica column (50 mm x 3.0 mm i.d.) at a flow-rate of 0.5 mL/min. Compounds were eluted using a mobile phase of 5 mm ammonium acetate and 0.1% formic acid in water-0.1% formic acid in acetonitrile, 17:83 (v/v). MS/MS detection was carried out with an MDS-Sciex API3000 triple quadrupole mass spectrometer in positive electrospray ionization mode. The standard curve was linear from 0.05 to 50 ng/mL (r >= 0.9968). The lower limit of quantitation was 0.05 ng/mL. Good intra- and inter-day assay precision (within 7.4% RSD) and accuracy (within +/- 12.3%) were obtained. The extraction recovery was 66.2%. The method was successfully applied to preelinical pharmacokinetic studies in dogs. Copyright (c) 2008 John Wiley & Sons, Ltd.
引用
收藏
页码:763 / 769
页数:7
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