RP - HPLC Method Development&Validation for the Simultaneous Estimation of Encorafenib and Binimetinib in API&Tablet Dosage Form

A new RP-HPLC method was developed, validated and adapted for the estimation of encorafenib and binimetinib in bulk and tablet formulation. In this method, separation and assay of encorafenib and binimetinib was done in stationary phase using Agilent C18 column with mobile phase of 0.1M dipotassium hydrogen phosphate (pH 4.0) and methanol in 50: 50 vol/vol ratio. The Binimetinib was eluted at 3.448 min and encorafenib at 5.795 min. Linearity ranges are 7.5-22.5 g/ml and 37.5-112.50 g/ml with regression coefficient values of 0.9996 and 0.9997 for binimetinib and encorafenib respectively. The LOD values found were binimetinib � 0.017 �g/ml and encorafenib � 0.114 �g/ml, and the LOQ values of binimetinib � 0.058 �g/ml and encorafenib � 0.381 �g/ml. Validation parameters examined following suggestions of ICH are accurateample for the supposed assay. The approach is confirmed as splendidmethod for assay of encorafenib and binimetinib in tablet formula with excellent assay percentage values.