A new stability indicating HPTLC method development and validation for estimation of trimetazidine dihydrochloride and metoprolol tartrate

A simple, newand rapid stability indicating HPTLC method has been developed and validated for estimation of Trimetazidine Dihydrochloride and Metoprolol Tartrate in combination. These drugs are available as tablets for the treatment of ischemia. Chromatographic separation of the drugs was performed on aluminum plates pre-coated with silica gel 60 F₂₅₄ as the stationary phase and the solvent system consisted of n-butanol: methanol: ammonia (10:4:2 v/v/v). Densitometric evaluation of the separated zones was performed at 225 nm. The two drugs were satisfactorily resolved with Rf values 0.26, and 0.70 for Trimetazidine Dihydrochloride and Metoprolol Tartrate, respectively. The linearity was observed in the range of 700-3500 ng/band for Trimetazidine Dihydrochloride and 1000-5000 ng/band for Metoprolol Tartrate. Both drugs were exposed to stress degradation conditions like hydrolysis at different pH, oxidation, photolytic and thermal degradation. The developed method was validated according to ICH guidelines. The method can be used for the routine quantitative determination of Trimetazidine dihydrochloride and Metoprolol tartrate in combination.