Bioequivalence Study of Toriem®Tablet to Motilium-M®Tablet (Domperidone Maleate 12.72 mg) Evaluated by Liquid Chromatography/Tandem Mass Spectrometry

The aim of the present study was to evaluate the bioequivalence of two domperidone maleate tablets, Motilium- Tablet (Janssen Korea Ltd., reference product) and Tablet (Daewon Pharm. Co., Ltd., test product). Domperidone was extracted by liquid-liquid extraction using tert-butyl methyl ether and separated in less than 3 min on reverse-phase column using an isocratic elution. A tandem mass spectrometer, as detector, was used for quantitative analysis in positive mode by a multiple reaction monitoring mode to monitor the m/z and the m/z transitions for domperidone and the internal standard (roxithromycin), respectively. Calibration curves, from ng/mL of domperidone, showed correlation coefficients (r) higher than 0.9941. Intra day and inter day precision (C.V. %) for quality control were ranged from 10.04 to 16.09% and from 10.87 to 18.69%, respectively. The lower limit of quantification (LLOQ) of domperidone was 0.05 ng/mL. The method described is precise and sensitive and has been successfully applied to the study of bioequivalence of domperidone in 24 healthy Korean volunteers. Twenty-four healthy male Korean volunteers received a single dose of each medicine ( domperidone maleate) in a crossover study. There was a one-week washout period between the doses. Plasma concentrations of domperidone were monitored for over a period of 24 hr after the administration. (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. (maximum plasma drug concentration) and (time to reach ) were compiled from the plasma concentration-time data. The 90% confidence intervals for the log transformed data were within acceptable range of log 0.8 to log 1.25 (e.g., for , for ). The major parameters, and met the criteria of KFDA for bioequivalence indicating that tablet is bioequivalent to Motilium- tablet.