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Validation of an LC-MS/MS method for the quantitative determination of Mavoglurant (AFQ056) in human plasma

Jakab, Annamaria and Winter, Serge and Raccuglia, Marc and Picard, Franck and Dumitras, Swati and Woessner, Ralph and Mistry, Sanket and Chudasama, Jayraj and Guttikar, Swati and Kretz, Olivier (2013) Validation of an LC-MS/MS method for the quantitative determination of Mavoglurant (AFQ056) in human plasma. Analytical and Bioanalytical Chemistry, 405 (1). pp. 215-223. ISSN 1618-2642

Abstract

A simple, sensitive and selective liquid chromatography/tandem mass spectrometry (HPLC–MS/MS) 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 mm × 4.6 mm, 5 µm) column at 40 ± 0.5 oC with a mobile phase consisted of acetic acid in water (0.1% v/v): methanol (10:90, v/v) with a flow rate of 1.0 mL/min followed by quantification with tandem mass spectrometer, operated with electrospray ionization (ESI) in positive ion mode and applying multiple reaction monitoring (MRM). 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 10-fold dilution of samples. The method was validated using sodium heparin as specific anticoagulant and cross-validated using lithium heparin and K3EDTA. The method was specific for mavoglurant within the given criteria for acceptance (apparent peak area for mavoglurant in zero samples ≤ 20% of 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 2.00 ng/mL and 2500 ng/mL.

Item Type: Article
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Additional Information: The chemical structure of AFQ056 is shown in the article, but this has been already disclosed since previous publications have been issued. This information is coming from Phaninatha Ayalavajjala, the NVS scientific publishing group in India.
Keywords: AFQ056, Mavoglurant, mGluR5, LC-MS/MS, Stability, Human plasma, Recovery, Validation
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Date Deposited: 13 Oct 2015 13:14
Last Modified: 13 Oct 2015 13:14
URI: https://oak.novartis.com/id/eprint/8086

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