European Journal of Biomedical and Pharmaceutical Sciences

VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD FOR DETERMINATION OF TRIMETAZIDINE IN PHARMACEUTICAL DOSAGE FORMS

*Farzana Hasin, Sharja Noon, Hasib Al Hasan, Tajdika Jahan

ABSTRACT

A stability-indicating HPLC method was validated for the determination trimetazidine in tablet dosage form. The chromatographic conditions comprised of a 250 X 4.6 mm column containing 5-μm; packing L1 (C18), with a mobile phase consisting of mix 40 volumes of buffer and 60 volumes of methanol (Pass the solution through 0.45μmembrane filter and degas) with flow rate of 1.0 ml/min. Detection was carried out at 240 nm. The retention time of trimetazidine was found to be 3.0 min. The linear regression analysis data for the calibration plots showed good linear relationship within the concentration range 0.070-0.280 μg/ml. The value of correlation coefficient was found to be 1.00. The recovery of trimetazidine hydrochloride was about 98–102%. Trimetazidine dihydrochloride was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Trimetazidine is more sensitive to wards acidic degradation. The method was validated as per ICH guidelines.

Keywords: Trimetazidine, HPLC.