Development and Validation of HPTLC Method for the Estimation of Alectinib in Capsule Dosage Form

A new, simple, accurate, fast, economic and precise high performance thin layer chromatography (HPTLC) method was developed and validated for the estimation of alectinib in a capsule dosage form. Separation of active ingredient from alectinib capsule was done on pre-coated HPTLC plate (silica gel 60 F254) and mobile phase consisting of Toluene: Methanol: Ethyl acetate: Glacial acetic acid in the ratio of 6:2:2:1v/v/v/v. Analysis of alectinib was carried out at the wavelength of 340nm. This system well-resolved bands for alectinib at a Rf value of 0.4. The current method has been statistically validated in accordance with the ICH Q2 (R1) guidelines. Linearity was found to be in the concentration range of 100-1500ng/band with the correlation coefficient of 0.999. Good accuracy and precision were obtained as revealed from %RSD value less than 2.