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

Year 2024, Volume: 44 Issue: 4, 318 - 327, 01.12.2024

Anusha Gandi , Pavan Kumar Dudi , Eswar Sandeep Pantala , Varaprasada Rao K , Srinivasa Rao Yarguntla

https://doi.org/10.52794/hujpharm.1479058

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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