J Pharm Biomed Anal. 2005 Oct 4;39(5):1042-5. Epub 2005 Jun
Tseng YL, Uralets V, Lin CT, Kuo FH.
Institute of Pharmacology and Toxicology and Doping Control Center,
Tzu Chi University, 701 Section 3, Hualien, Taiwan.
Detection of modafinil in human urine by gas chromatography-mass spectrometry.
The main purpose of this study was to detect and quantify modafinil
in human urine by gas chromatography-mass spectrometry (GC-MS).
Urinary samples were collected from three healthy male volunteers following
oral administration of a clinical dose (100 mg) of modafinil (Provigil).
Urine specimens were extracted with t-butylmethyl ether (TBME) prior to
GC-MS analysis. The results demonstrate that the chromatographic characteristics
and the mass spectrum of the unchanged parent drug extracted from urine
samples were identical to that obtained from the authentic standard. The
times for the unchanged modafinil to reach peak concentration in the urine
of the three volunteers were at 2 h (6.14 microg/mL), 4 h (9.93 microg/mL)
and 8 h (3.58 microg/mL), respectively. Total clearance occurred in approximately
48-72 h with 2-5% eliminated through urine as unchanged modafinil.
The present study demonstrates that modafinil is detectable in the absence
of hydrolysis and derivatization steps.
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