Liquid chromatography-tandem mass spectrometry method for the determination of trimetazidine in human plasma.
A sensitive liquid chromatography-tandem mass spectrometry (LC/MS/MS) method was developed and validated for the determination of trimetazidine (CAS 13171-25-0) in human plasma, using pseudoephedrine as internal standard (IS). Plasma samples were simply pretreated with methanol for deproteinization. The chromatographic separation was performed on a C18 column with a mobile phase of 3 mmol/L ammonium acetate solution-methanol (15:85, v/v) at a flow rate of 0.3 mL/min. The chromatographic separation was achieved in less than 3.2 min. The linearity was established over the concentration range of 1-100 ng/mL. Both intra- and inter-batch standard deviations were less than 9.5%. The method was successfully applied to study the relative bioavailability of trimetazidine hydrochloride tablets in healthy Chinese volunteers and the pharmacokinetic parameters of the reference and test tablets were compared.
Zou
Jianjun
J
Department of Clinical Pharmacology, Nanjing First Hospital Affiliated to Nanjin Medical University, Nanjing, The People's Republic of China. zoujianjun100@126.com
Dai
Li
L
Wang
Guang Ji
GJ
Zhu
Yubing
Y
Fan
Hongwei
H
Xiao
Da Wei
da W
D000328:Adult; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D007202:Indicators and Reagents; D008297:Male; D011786:Quality Control; D012015:Reference Standards; D012996:Solutions; D013607:Tablets; D053719:Tandem Mass Spectrometry; D014292:Trimetazidine / Q000097:blood* / Q000493:pharmacokinetics; D014665:Vasodilator Agents / Q000097:blood* / Q000493:pharmacokinetics
D007202:Indicators and Reagents; D012996:Solutions; D013607:Tablets; D014665:Vasodilator Agents; D014292:Trimetazidine