SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF TRIMETAZIDINE DIHYDROCHLORIDE FROM PHARMACEUTICAL FORMS

In this paper there have been studied the experimental conditions of the reaction of nucleophile substitution between the trimetazidine dihydrochloride (TMZD) and 2,4 ‐ dinitro-fluorobenzene (DNFB) with the purpose of elaborating a new spectrophotometric method for the determination of TMZD in pharmaceutical forms (Tazidil®, Trimetazidine®, Preductal®). The physical and chemical conditions of the reaction have been studied, establishing the maximum wavelength (λ max ), using a T80 UV-VIS spectrophotometer, the concentration of the reacting substances, the pH, the temperature and the combination ratio. The elaborated method was validated for the TMZD determination in pharmaceuticals. The evaluation of some statistical parameters of validation recommends this method for the TMZD determination at λ= 385 nm in the concentration limits 0.4µg/mL2.56µg/mL. The validation studies proved the precision, the accuracy, the linearity of the elaborated method Rezumat In această lucrare au fost studiate condiţiile experimentale ale reacţiei de substituţie nucleofilă dintre clorhidratul de trimetazidină (TMZD) si 2,4-dinitrofluorobenzen (DNFB), cu obţinerea unui complex colorat in galben si cu lungimea de undă de absorbţie maximă la λ=385 nm. S-au stabilit parametrii experimentali ai reacţiei (pH-ul, temperatura, concentraţia reactivului, raportul de combinare) si s-a validat metoda spectrofotometrică UV-VIS de determinare a TMZD ca atare si din forme farmaceutice.