SPECTROPHOTOMETRIC METHOD FOR
THE DETERMINATION OF
TRIMETAZIDINE DIHYDROCHLORIDE
FROM PHARMACEUTICAL FORMS.
ADRIANA AURELIA CHI޹*, FELICIA GABRIELA GLIGOR²,
GABRIELA CORMO޲ , ELENA CUREA³, MARIUS BOJIŢĂ³
1S.C. Polisano S.R.L., 30A Semaforului, Sibiu
² ˝Lucian Blaga˝ University, Faculty of Medicine, Sibiu
³ ˝Iuliu Hatieganu˝ University of Medicine and Pharmacy Cluj –
Napoca, Faculty of Pharmacy, 6 Pasteur, Cluj- Napoca
*corresponding author: adriana.chis@polisano.ro
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Abstract:
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 (λmax), 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= 385nm in the concentration limits 0.4μg/mL- 2.56μg/mL. The validation studies proved the precision, the accuracy, the linearity of the elaborated method.
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