Development And Validation Of High-Performance Thin Layer Chromatography Method For Simultaneous Estimation Of Aripiprazole And Clozapine In Marketed Combined Dose Tablets Formulations

Abstract

The present work demonstrated the use of a simple validated High-Performance Thin-Layer Chromatography method has been proposed for the simultaneous determination of Aripiprazole (ARI) and Clozapine (CLO) in a tablet dosage form. Materials and methods:  The separation was achieved on silica gel 60 F254 coated aluminum sheet as stationary phase using Toluene: Methanol (7.5: 2:5 v/v) as mobile phase which gave compact spots with Rf values 0.51 ± 0.02 for ARI and 0.72 ± 0.03 for CLO. Quantitative densitometric evaluation was done in absorbance-reflectance mode at 258 nm. The developed method was validated with respect to linearity, limits of detection and quantitation, accuracy, precision, specificity and robustness. Results: For proposed method, the response was found to be linear over concentration range of 100-500 ng/spot for ARI and 500-2500 ng/spot for CLO with correlation coefficients 0.997 by peak height and 0.997 by peak area for ARI and 0.996 by peak height and 0.997 by peak area for CLO. The mean percentage recovery of the drug was observed to be 99.79 ± 0.864 by peak height and 100.3 ± 0.699 by peak area for ARI and 99.59 ± 0.578 by peak height and 100.46 ± 0.670 by peak area, respectively. The suitability of method for the quantitative determination of Aripiprazole (ARI) and Clozapine (CLO) was proved by validation. Conclusion: The method was validated for linearity, accuracy, range, precision and robustness according to International Council on Harmonization Q2 (R1) guidelines. The method is simple, accurate, precise and was successfully applied to the assay of drug in tablet formulation. Conclusion:  The proposed method and its results had been successfully applied and validated to the simultaneous estimation of Aripiprazole and Clozapine in their combination for quality analysis.