Application of liquid chromatography method with electrochemical detection for bioequivalence study of trimetazidine in human plasma
Grabowski, T.; Swierczewska, A.; Borucka, B.; Sawicka, R.; Sasinowska-Motyl, M.łg.; Gumułka, S.ła.W.
Acta Poloniae Pharmaceutica 69(6): 1009-1016
2012
ISSN/ISBN: 0001-6837 PMID: 23285659 Document Number: 659202
A method to estimate trimetazidine (CAS: 13171-25-0) levels in human plasma by means of HPLC with electrochemical detection was developed. Trimethoprim (CAS: 26807-65-8) was used as an internal standard. This method of analysis was fully validated according to the guidelines of the United States Food and Drug Administration, European Medicines Agency and Organization for Economic Co-operation and Development and Good Laboratory Practice rules. The accuracy and precision of the developed method were found to be satisfactory and stability studies showed acceptable variation (below 15%) of trimetazidine concentrations when samples were stored frozen at -75 degrees C for 54 days. The developed method was successfully used for a comparative 2 x 2 period, crossover bioequivalence study of two extended-release preparations of trimetazidine performed on 24 healthy volunteers at the steady state after multiple dosing of 35 mg twice daily for 4 days and a single 35 mg dose on the 5th day and after a single dose of 35 mg under fasting or postprandial conditions.