HPTLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF ALECTINIB HYDROCHLORIDE IN BULK POWDER AND CAPSULE PREPARATIONS

Abstract

The high performance thin layer chromatography method described here enables simple, accurate and precise estimation of alectinib hydrochloride content in capsule formulation. To achieve adequate separation, G60 - F254 pre-coated silica gel sheets of aluminium were used as the stationary phase. A mobile phase comprising a solvent mixture of methanol and water in a ratio of 80:20 (V/V) was utilized with a chamber saturation duration of 30 minutes. The retardation factor value was found to be 0.47 at the detection wavelength 341 nm. The method’s linearity was confirmed across a concentration range from 600 - 2100 ng band-1, exhibiting a high correlation coefficient of 0.9992. The accuracy range was observed between 98.50 % – 100.45 %. The lowest detection limits of drug were observed to be 17.49 ng band-1 and lowest quantitation limits of drug were found to be 53.01 ng band-1. This developed methodology was effectively employed for the quantification of alectinib hydrochloride in capsule preparations