Liquid Chromatography-Electrospray Quadrupole Linear Ion Trap Mass Spectrometric Method for Quantitation of Domperidone in Chinese Healthy Volunteers*

A rapid, sensitive, and accurate method based on LC/MS/MS was developed and validated for the determination of domperidone in human plasma. Domperidone and internal standard, tramadol, were extracted from plasma with diethyl ether-dichloromethane(60:40, volume ratio) and separated by reversed-phase HPLC with methanol-water-ammonia solution(80:20:0. 2, volume ratio) as the mobile phase. Detection was carried out via multiple-reaction monitoring(MRM) on a Q-trapTM LC/MS/MS system(Q-trapTM). The assay result was linear over a concentration range of 0. 1-30 ng/mL with a limit of quantitation (LOQ) of 0. 1 ng/mL. The inter- and intra-day precision levels were within 7. 52% and 12. 9%, respectively, whereas the accuracy was within a range of 87. 3%-114%. This method has been successfully applied to evaluate the pharmacokinetics of domperidone in Chinese healthy volunteers given an oral dose of 10 mg.