RP-HPLC method development and validation for estimation of Alectinib in bulk and pharmaceutical dosage form

Abstract

A simple, Précised, Accurate method was developed for the estimation of Alectinib   by RP-HPLC technique. Chromatographic conditions used are stationary phase Zodiasil 150mm x 4.6 mm, 5mm, Mobile phase Water;Acetonitrile (50:50) and flow rate was maintained at 1ml/min, detection wave length was 265nm, column temperature was set to 30^oC and diluent was mobile phase Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R² value was found to be as 0.999.Precision was found to be 1.0 for repeatability and 0.5 for intermediate precision.LOD and LOQ are 0.62µg/ml and 1.88 µg/ml respectively. By using above method assay of marketed formulation was carried out 100.65% was present.  Degradation studies of Alectinib were done, in all conditions purity threshold was more than purity angle and within the acceptable range. Full length method was not performed; if it is done this method can be used for routine analysis of Alectinib.