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


CONCLUSIONS
The method described in this report was of high sensitivity and selectivity for accurate determination of the plasma concentration of domperidone in human.
Wu
Min-Shu
MS
Center of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing 210009, China.
Gao
Ling
L
Cai
Xiao-Hui
XH
Wang
Guang-Ji
GJ
D000328:Adult; D002853:Chromatography, Liquid / Q000379:methods; D004294:Domperidone / Q000097:blood* / Q000493:pharmacokinetics; D018492:Dopamine Antagonists / Q000097:blood* / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods
D018492:Dopamine Antagonists; D004294:Domperidone