Abstract

A simple and sensitive method was developed for determination of fexofenadine by liquid chromatography with fluorescence detection. Fexofenadine in human plasma was extracted on a C18 bonded-phase extraction cartridge. The mobile phases were: (A) 0.05M KH2PO4 buffer/acetonitrile/methanol (60:35:10, v/v/v) and (B) 0.05M KH2PO4 buffer/acetonitrile (40:60, v/v). Chromatographic separation was achieved on an ODS-80A column (150mm×4.6mm i.d., particle size 5μm) using a linear gradient from A to B in 10min. The peak was detected using a fluorescence detector set at Ex 220nm and Em 290nm, and the total time for a chromatographic separation was ∼17min. The validated quantitation ranges of this method were 1.0–500ng/ml with coefficients of variation of 0.6–9.1%. Mean recoveries were 72.8–76.7% with coefficients of variation of 2.7–5.8%. This method is successfully applicable for therapeutic drug monitoring in patients treated with clinical doses of fexofenadine and for analyses within pharmacokinetic studies.

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