Analytical Method Development and Validation of An HPTCL Method of Combination of Aripiprazole and Clozapine By QBD Approach

Abstract

For the simultaneous estimation of Clozapine and Aripiprazole in combination, a sensitive and precise High Performance Thin Layer Chromatographic (HPTLC) method has been developed. The stationary phase was pre-coated silica gel 60 F254 on HPTLC aluminium plates, and the solvent system was Toluene: Methanol: Ethyl Acetate: Ammonia (6.5:2.5:0.5:0.15,v/v/v/v). Clozapine and Aripiprazole were found to have Rf values of 0.43 and 0.53, respectively. The HPTLC study was performed at a wavelength of 254 nm. Clozapine was found to be linear in the range of 50-300 ng per band, while Aripiprazole was found to be linear in the range of 25-150 ng per band. The Box Behnken design was used to optimize the system using the QbD technique. The procedure was validated and successfully applied for the calculation of both drugs in the synthetic mixture of API as well as marketed formulation.