Authors: Annamaria Jakab Serge Winter Marc Raccuglia Frank Picard Swati Dumitras Ralph Woessner Sanket Mistry Jayraj Chudasama Swati Guttikar Olivier Kretz
Publish Date: 2012/10/13
Volume: 405, Issue: 1, Pages: 215-223
Abstract
A simple sensitive and selective liquid chromatography/tandem mass spectrometry method was validated for the identification and quantification of mavoglurant AFQ056 in human plasma The chromatographic separation was performed using a Cosmosil 5 C18 150 × 46 mm 5 μm column at 40 ± 05 °C with a mobile phase consisting of acetic acid in water 01 v/v/methanol 1090 v/v with a flow rate of 10 mL/min followed by quantification with tandem mass spectrometry operating with electrospray ionization in positive ion mode and applying multiple reaction monitoring The validated method described in this paper presents high absolute recovery with precision and accuracy meeting the acceptance criteria The method was precise and accurate for 2 and 10fold dilution of samples The method was validated using sodium heparin as specific anticoagulant and the anticoagulant effect was tested by lithium heparin and K3EDTA The method was successfully crossvalidated between two bioanalytical sites The method was specific for mavoglurant within the given criteria for acceptance apparent peak area at the retention time of mavoglurant in zero samples was less than 20 compared with the mean peak area at LLOQ in human plasma The method was fully validated for the quantitative determination of mavoglurant in human plasma between the range of 200 and 2500 ng/mL
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