Determination of itopride in human plasma by liquid chromatography coupled to tandem mass spectrometric detection: application to a bioequivalence study.
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 C18 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 (r2=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.
Lee
Heon-Woo
HW
College of Pharmacy, Kyung Hee University, Hoegi-Dong, Dongdaemun-Ku, Seoul 130-701, Republic of Korea.
Seo
Ji-Hyung
JH
Choi
Seung-Ki
SK
Lee
Kyung-Tae
KT
D001549:Benzamides / Q000097:blood* / Q000302:isolation & purification; D001593:Benzyl Compounds / Q000097:blood* / Q000302:isolation & purification; D002138:Calibration; D002853:Chromatography, Liquid / Q000379:methods; D006801:Humans; D007202:Indicators and Reagents; D013058:Mass Spectrometry / Q000379:methods; D012996:Solutions; D012997:Solvents; D013469:Sulpiride / Q000097:blood / Q000302:isolation & purification; D013810:Therapeutic Equivalency
D001549:Benzamides; D001593:Benzyl Compounds; D007202:Indicators and Reagents; D012996:Solutions; D012997:Solvents; D013469:Sulpiride; C102254:itopride