A Comprehensive New Approach to Method Development and Validation of Encorafenib using UV Spectroscopy in Bulk and Pharmaceutical Formulation

Abstract

Encorafenib is a class of anti-cancer medication used to treat cancer infections. It is a selective BRAF inhibitor, has emerged as a promising therapeutic agent in the treatment of metastatic melanoma. This research endeavors to introduce a fresh approach and authenticate a UV spectrophotometric technique for examining encorafenib in pharmaceutical formulations. A unique, precise, and cost-effective UV spectrophotometric procedure has been devised using a blend of phosphate buffer and acetonitrile (90:10). Various standard solutions ranging from 10 to 70 μg/ml of the drug were evaluated for their absorbance at 235nm against a blank solution. The method exhibited a linear dynamic range of 10.0–70.0 µg/ml with an impressive correlation coefficient (r2=0.9996) and a regression equation of y =0.0102x-0.0049. Intra- and inter-precisions displayed relative standard deviations (RSD) below 2.0%. The limits of detection (LOD) and quantification (LOQ) were determined as 0.159 µg/ml and 0.483 µg/ml respectively. All validation parameters adhered to the stipulated limits outlined in ICH guidelines. This approach has the potential to be a valuable asset for regular quality assessment in pharmaceutical labs contributing to the assurance of safety and efficacy in medications containing Encorafenib.

Keywords

• Encorafenib
• UV Spectrophotometric method
• Phosphate Buffer
• Acetonitrile
• Method validation

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