Determination of itopride in human plasma by liquid chromatography coupled to tandem mass spectrometric detection: Application to a bioequivalence study [An article from: Analytica Chimica Acta]

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Description:
A simple method using a one-step liquid-liquid extraction (LLE) with butyl acetate followed by high-performance liquid chromatography (HPLC) with positive ion electrospray ionization tandem mass spectrometric (ESI-MS/MS) detection was developed for the determination of itopride in human plasma, using sulpiride as an internal standard (IS). Acquisition was performed in multiple reaction monitoring (MRM) mode, by monitoring the transitions: m/z 359.5>166.1 for itopride and m/z 342.3>111.6 for IS, respectively. Analytes were chromatographed on an YMC C"1"8 reverse-phase chromatographic column by isocratic elution with 1mM ammonium acetate buffer-methanol (20: 80, v/v; pH 4.0 adjusted with acetic acid). Results were linear (r^2=0.9999) over the studied range (0.5-1000ngmL^-^1) with a total analysis time per run of 2min for LC-MS/MS. The developed method was validated and successfully applied to bioequivalence studies of itopride hydrochloride in healthy male volunteers.