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Comparison of LC‐UV and LC–MS methods for simultaneous determination of teriflunomide, dimethyl fumarate and fampridine in human plasma: application to rat pharmacokinetic study
Author(s) -
Suneetha A.,
Raja Rajeswari K.
Publication year - 2016
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.3694
Subject(s) - chemistry , chromatography , teriflunomide , ammonium formate , dimethyl fumarate , detection limit , high performance liquid chromatography , pharmacokinetics , analyte , acetonitrile , human plasma , multiple sclerosis , fingolimod , pharmacology , medicine , psychology , psychiatry
This study describes a comparison between LC‐UV and LC–MS method for the simultaneous analyses of a few disease‐modifying agents of multiple sclerosis. Quantitative determination of fampridine (FAM), teriflunomide (TFM) and dimethyl fumarate (DMF) was performed in human plasma with the recovery values in the range of 85–115%. A reversed‐phase high‐performance liquid chromatography (HPLC) with UV as well as MS detection is used. The method utilizes an XBridge C 18 silica column and a gradient elution with mobile phase consisting of ammonium formate and acetonitrile at a flow rate of 0.5 mL min −1 . The method adequately resolves FAM, TFM and DMF within a run time of 15 min. Owing to low molecular weights, the estimation of DMF and FAM is more versatile in UV than MS detection. With LC‐UV, the detection limits of FAM, TFM and DMF were 0.1, 0.05, 0.05 μg and the quantification limit for all the analytes was 1 μg. With LC–MS, the detection and quantification limits for all of the analytes were 1 and 5 ng, respectively. The two techniques were completely validated and shown to be reproducible and sensitive. They were applied to a pharmacokinetic study in rats by a single oral dose. Copyright © 2016 John Wiley & Sons, Ltd.