Determination of domperidone in human plasma by LC-MS and its pharmacokinetics in healthy Chinese volunteers

AIM: To determine the concentration of domperidone in human plasma and investigate its pharmacokinetics in Chinese male volunteers following oral administration of a single dose of the medicine 20 mg. METHODS: Plasma samples were processed by liquid-liquid extraction and a liquid chromatographic-mass spectrometric assay was developed for the determination of domperidone in human plasma. RESULTS: Assay linearity was obtained in the range of 0.52 - 154.5 μg/L (r = 0.9999). The recovery of domperidone from human plasma was more than 75 %. The intraday and interday relative standard deviations (RSD) for the lowest concentration examined (0.52 μg/L) were 9.4 % and 7.6 %, respectively. The method was utilized to determine the concentration of domperidone in Chinese male volunteers. The concentration-time curve was fitted to a two-compartment model. Its main pharmacokinetic parameters were: T_max=(0.8±0.7) h, C_max=(50±32) μg/L, T_1/2=(7.8±1.6) h. CONCLUSION: The method described in this report was of high sensitivity and selectivity for accurate determination of the plasma concentration of domperidone in human.