Application of quality by design in the development of HPTLC Method for the estimation of ceritinib in bulk and synthetic mixture

The aim of the present work is to develop and validate the High-Performance Thin Layar Chromatography method for the estimation of Ceritinib in bulk and synthetic mixture using the Analytical Quality by Design (AQbD) approach as per ICH Q8 (R2). The AQbD is used to develop a precise HPTLC method. The AQbD parameter elements like QTMP (Quality Target Method Profile- Ceritinib, method type, instrument requirement, sample characteristics, synthetic mixture preparation) CMA—Critical method attributes (chloroform ± 1 ml, methanol ± 1 ml, triethylamine ± 0.05), and Risk assessment (the Ishikawa (fishbone) diagram) were carried out for the development of the HPTLC method for Cerinitib. The Box-Behnken design was utilized for the optimization of chromatographic conditions in HPTLC. The method utilized an aluminum HPTLC plate pre-coated with silica gel G60 F254 as a stationary phase along with chloroform: methanol: triethylamine (8.9: 1.6: 0.07 v/v/v) as a mobile phase. ANOVA results and perturbation plot indicates that methanol and triethylamine had more impact than chloroform on the retardation factor. The retardation factor was found to be 0.37. The absorbance mode at 277 nm was used for the densitometric study. It was found that the linearity ranged from 20 to 100 ng/band, with a correlation coefficient of 0.998. No interference was observed from excipients and mobile phase solvents. The results indicate that the AQbD approach is effectively applied to optimize the retardation factor and the method is appropriate for routine laboratory analysis.