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Liquid chromatography tandem mass spectrometry assay to determine the pharmacokinetics of aildenafil in human plasma.

Wang J, Jiang Y, Wang Y, Zhao X, Cui Y, Gu J

Research Center for Drug Metabolism, College of Life Science, Jilin University, Changchun 130023, China.

A simple, sensitive and specific liquid chromatography/tandem mass spectrometry method for the quantitation of aildenafil, a new phosphodiesterase V inhibitor, in human plasma is presented. The analyte and internal standard, sildenafil, were extracted by a one-step liquid-liquid extraction in alkaline conditions and separated on a C(18) column using ammonia:10mM ammonium acetate buffer:methanol (0.1:15:85, v/v/v) as the mobile phase. The detection by an API 4000 triple quadrupole mass spectrometer in multiple-reaction monitoring mode was completed within 2.5 min. The calibration curve exhibited a linear dynamic range of 0.05-100 ng/ml with a 10 pg/ml limit of detection. The intra- and inter-day precisions measured as relative standard deviation were within 8.04% and 5.72%, respectively. This method has been used in a pharmacokinetic study of aildenafil in healthy male volunteers each given an oral administration of one of the three dosages.

Published 16 April 2007 in J Pharm Biomed Anal, 44(1): 231-5.
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