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Stability indicating HPTLC determination of Trimetazidine as bulk drug and in pharmaceutical formulations
S O Thoppil1, R M Cardoza, P D Amin
1Pharmaceutical Division, Department of Chemical Technology (Autonomous), University of Mumbai, Nathalal Parikh Marg, Matunga, Mumbai 400 019, India.
Abstract:
A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of trimetazidine hydrochloride both as a bulk drug and in formulations is reported. The mobile phase composition was n-butanol-water-methanol-ammonia (20%) (14:0.2:0.2:2, v/v/v/v). Densitometric analysis of trimetazidine hydrochloride was carried out in the absorbance mode at 254 nm. the calibration curve of trimetazidine hydrochloride in methanol was linear in the range 400 -- 2400 ng. The mean value of correlation coefficient, slope and intercept were 0.99815 and #61617;0.001, 0.4849 and #61617;0.001 and 31.633 and #61617;5.996 respectively. The limits of detection and quantitation were 50 and 80 ng respectively. The recovery of trimetazidine hydrochloride was about 98 -- 100%. This method was utilized to analyze trimetazidine hydrochloride from conventional tablets and controlled release pellets in the presence if commonly used excipients.
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