Development of an RP-HPLC Method for the Simultaneous Quantification of Encorafenib and Cetuximab in their Bulk Form

The primary goal of this investigation was to develop and validate a high-performance liquid chromatograophy (HPLC) method that is straightforward, reliable, sensitive, and accurate in quantifying the concentrations of encorafenib and cetuximab in bulk form. A Waters HPLC system with an autosampler and a PDA detector was used to create the HPLC technique. With a particle size of 5 μ and dimensions of 250 x 4.6 mm, a Waters X-Terra RP-18 column was used for the separation. A combination of acetonitrile and 0.1% triethylamine (TEA) at a pH of 2.5 makes up the mobile phase. Acetonitrile to TEA is 40:60 in ratio. A 240 nm wavelength, a 10 μL injection volume, and a flow rate of 1.0 mL/min were used for the chromatographic procedure. Analyte serial dilutions will be evaluated in order to establish linearity. The stock solutions with concentrations ranging from 1.25 to 7.50 μg/mL for cetuximab and 18.75 to 112.50 μg/mL for encorafenib were used to generate these dilutions. The dilutions were made by adding the mobile phase to the stock solutions to create a series. Encorafenib and cetuximab were found to have limit of detection (LoD) and limit of quantitation (LoQ) values of 0.225 and 0.015 g/mL and 0.75 and 0.05 g/mL, respectively. The method that was developed showed a high level of accuracy, as evidenced by the relative standard deviation (RSD) being less than 2%. The developed analytical method for estimating encorafenib and cetuximab is both straightforward and accurate.