Determination of itopride in human plasma by liquid chromatography coupled to tandem mass spectrometric detection: Application to a bioequivalence study

• Published in: Analytica chimica acta Vol. 583; no. 1; pp. 118 - 123
• Main Authors: Lee, Heon-Woo, Seo, Ji-Hyung, Choi, Seung-Ki, Lee, Kyung-Tae
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 30.01.2007; Elsevier
• Subjects: Analytical chemistry; Benzamides - blood; Benzamides - isolation & purification; Benzyl Compounds - blood; Benzyl Compounds - isolation & purification; Bioequivalence; Calibration; Chemistry; Chromatographic methods and physical methods associated with chromatography; Chromatography, Liquid - methods; Exact sciences and technology; Human plasma; Humans; Indicators and Reagents; Itopride; Liquid chromatography/tandem mass spectrometry; Liquid–liquid extraction; Mass Spectrometry - methods; Other chromatographic methods; Solutions; Solvents; Spectrometric and optical methods; Sulpiride - blood; Sulpiride - isolation & purification; Therapeutic Equivalency; Liquid–liquid extraction; Human plasma; Liquid chromatography/tandem mass spectrometry; Bioequivalence; Itopride; Human; Plasma; Ammonium; Liquid liquid extraction; Internal standard; HPLC chromatography; Liquid chromatography; Acetate; Electrospray; Chemical ionization; Chemical enrichment; Positive ion; Liquid-liquid extraction; Hydrochlorides; Mass spectrometry MS/MS; Time analysis; Monitoring; Methanol
• ISSN: 0003-2670; 1873-4324
• DOI: 10.1016/j.aca.2006.09.061

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 18 reverse-phase chromatographic column by isocratic elution with 1 mM 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 (0.5–1000 ng mL −1) with a total analysis time per run of 2 min for LC-MS/MS. The developed method was validated and successfully applied to bioequivalence studies of itopride hydrochloride in healthy male volunteers.