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Biomed Chromatogr. 2018 Nov;32(11):e4342. doi: 10.1002/bmc.4342. Epub 2018 Aug 7.

Quantitative determination of armodafinil in human plasma by liquid chromatography-electrospray mass spectrometry: Application to a clinical study.

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Department of Pharmaceutics, University of Florida, Gainesville, Gainesville, Florida, USA.


Armodafinil is a wake-promoting agent approved in 2007 by the US Food and Drug Administration for the treatment of excessive sleepiness. A rapid, sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of armodafinil in human plasma was developed and validated. Armodafinil and internal standard (armodafinil d-10) were extracted from human plasma using protein precipitation combined with liquid-liquid extraction. This developed method only requires 50 μL of plasma for the analysis. The chromatographic separation was performed with a Waters symmetry, C18 , 4.6 × 150 mm, 5 μm column using formic acid, water and acetonitrile as solvent delivered at a 0.7 mL/min flow rate. The total run time of the method was 3 min. The method was validated according to regulatory guidance in terms of specificity, selectivity, linearity, matrix effect, recovery and stability. Optimized Q1/Q3 mass transitions for armodafinil and armodafinil d-10 were 274.1/167.2 (m/z) and 284.4/177.4 (m/z) respectively. The method showed linearity within the tested concentration range of 10-10,000 ng/mL. The method was successfully applied to quantify armodafinil concentrations after single oral administration of a 250 mg tablet in a clinical study conducted in healthy volunteers. Significant advantages of this method are minimal sample volume, short run time and a lower LLOQ.


Ar; LC-MS/MS; clinical study; modafinil; pharmacokinetics

[Available on 2019-11-01]
[Indexed for MEDLINE]

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