quantitative determination of abt-925 in human plasma by on-line spe and lc-msms validation and sample analysis in phase ii studies定量测定人血浆的abt - 925在线spe和lc-msms验证和样品分析在第二阶段的研究.pdfVIP

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quantitative determination of abt-925 in human plasma by on-line spe and lc-msms validation and sample analysis in phase ii studies定量测定人血浆的abt - 925在线spe和lc-msms验证和样品分析在第二阶段的研究.pdf

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quantitative determination of abt-925 in human plasma by on-line spe and lc-msms validation and sample analysis in phase ii studies定量测定人血浆的abt - 925在线spe和lc-msms验证和样品分析在第二阶段的研究

Pharmaceutics 2010, 2, 171–181; doi:10.3390/pharmaceutics2020171 OPEN ACCESS pharmaceutics ISSN 1999-4923 /journal/pharmaceutics Article Quantitative Determination of ABT-925 in Human Plasma by On-Line SPE and LC-MS/MS: Validation and Sample Analysis in Phase II Studies Katty Wan *, Matthew Rieser and Tawakol El-Shourbagy Abbott/100 Abbott Park Road, Abbott Park, IL 60064, USA; E-Mails: matthew.j.rieser@ (M.R.); tawakol.a.elshourbagy@ (T.E.) ∗ Author to whom correspondence should be addressed; E-Mail: xia.wan@; Tel.: +1-847-938-0495; Fax: +1-847-938-7789. Received: 6 April 2010; in revised form: 29 April 2010 / Accepted: 30 April 2010 / Published: 4 May 2010 Abstract: A fully automated 96-well On-Line Solid Phase Extraction (SPE) followed by High Performance Liquid Chromatography (HPLC)-Tandem Mass Spectrometric (MS/MS) method for the determination of ABT-925 (2-{3-[4-(2-tert-Butyl-6- trifluoromethyl-pyrimidin-4-yl)-piperazin- 1-yl)-propyl-sulfanyl}-3H-pyrimidin-4-one fumarate) in human plasma was developed, validated and utilized in Phase II clinical studies. 50 µL of plasma sample was fortified with internal standard (IS, d8-ABT-925) and extracted on-line with Cohesive Turbo Flow Cyclone P HTLC column. The chromatographic separation was performed on Aquasil C18 (3 μm 50 × 3 mm) HPLC column with a mobile phase consisting of 50/50/0.1 (v/v/v) ACN/H2O/formic acid. The mass spectrometric measu