Stability-Indicating High-Performance Thin-Layer Chromatographic Method for the Estimation of Antipsychotic Drug Combination Clozapine and Aripiprazole

A sensitive and precise high-performance thin-layer chromatographic (HPTLC) method has been developed for the simultaneous estimation of clozapine and aripiprazole in combination. The method employed HPTLC aluminum plates pre-coated with silica gel 60 F-254, as the stationary phase, while the solvent system was toluene-methanol-ethyl acetate-ammonia (6.5:2.5:1:0.1, v/v). The R-F values were observed to be 0.43 and 0.60 for clozapine and aripiprazole, respectively. Densitometric analysis was carried out in absorbance mode at 218 mn. The method was linear in the range of 200-1600 ng per band for clozapine and 100-800 ng per hand for aripiprazole. The stress degradation study was performed, and it was found that clozapine was susceptible to acid hydrolysis, base hydrolysis, and photolytic degradation study. Aripiprazole was susceptible to oxidative stress degradation study. The method was validated and applied successfully for the estimation of both drugs in the synthetic mixture.