Details

Autor(en) / Beteiligte

• Ding, Li-kun
• Yang, Lin
• Chen, Su-ning
• Li, Jian-Kang
• Wen, Ai-dong

Titel

Simultaneous determination of subutinib and its active metabolite in human plasma by LC–MS/MS: Application to pharmacokinetic study

Ist Teil von

• Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2015-09, Vol.1001, p.22-26

Ort / Verlag

Netherlands: Elsevier B.V

Erscheinungsjahr

2015

Quelle

MEDLINE

Beschreibungen/Notizen

• •LC–MS/MS method was developed for determination of subutinib in human plasma.•It is successfully applied to pharmacokinetic study of subutinib.•This is first time to report the pharmacokinetic of subutinib maleate capsules. A selective liquid chromatographic–mass spectrometric method (LC–MS/MS) has been established and validated for simultaneous determination of subutinib and its active metabolite in human plasma. Plasma samples were extracted by liquid–liquid extraction with ethyl acetate and separated on a Wondasil C18 (150mm×2.1mm, 3.5μm), with methanol–0.2% formic acid solution (73:27, v/v) as mobile phase at flow rate of 0.2ml/min. The linear range was 0.25–100ng/mL for subutinib and 0.125–50.0ng/mL for its active metabolite, with lower limit of quantitation of 0.25ng/mL and 0.125ng/mL, respectively. Intra- and inter-run precision were within 7.0 and 13.1%, and the accuracies (relative errors) were<7.0 and 8.0%, with the extraction recoveries 97.0–101.2% and 93.0–98.1% for the two analytes, respectively. The validated method was successfully applied to a pharmacokinetic study of subutinib and its active metabolite in human after oral administration of subutinib maleate capsules.