Original Article

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

Authors: Min-Shu WU, Ling GAO, Xiao-Hui CAI, Guang-Ji WANG


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 microg/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 microg/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: Tmax = (0.8 +/- 0.7) h, Cmax = (50 +/-
32) microg/L, T1/2 = (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.

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