World Journal of
Pharmaceutical and Life Sciences

PHARMACEUTICAL ANALYTICAL REVIEW OF SORAFENIB

Dr. Osman Ahmed*, Alufa Tahreem and Dr. Anas Rasheed

ABSTRACT

Background: Sorafenib is an oral multi-kinase inhibitor used for treating advanced renal cell carcinoma, hepatocellular carcinoma, and thyroid cancer. Despite its efficacy, Sorafenib's chemical complexity and susceptibility to degradation under stress conditions necessitate robust analytical methodologies. Effective quality control is critical to ensuring its safety, potency, and stability in pharmaceutical formulations. Aim: To explore and review the various analytical methods developed for Sorafenib, focusing on chromatographic techniques, impurity profiling, and stability-indicating studies to support regulatory compliance and quality assurance. Research Methodology: This review highlights chromatographic methods such as HPLC and UPLC, with emphasis on mobile phase optimization, forced degradation studies, and impurity profiling. Spectroscopic methods like UV-Vis, FTIR, NMR, and MS are discussed for their roles in structural elucidation and degradation product identification. Stability studies conducted under acidic, basic, oxidative, thermal, and photolytic stress conditions are detailed to assess Sorafenib's behavior under various environmental challenges. Conclusion: Advanced analytical methods, including UPLC and LC-MS/MS, provide robust platforms for impurity profiling and stability evaluation of Sorafenib. These approaches ensure compliance with regulatory standards, supporting its safe and effective use in pharmaceutical applications.

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