World Journal of
Pharmaceutical and Life Sciences

DEGRADATION UNDER STRESS CONDITIONS: A DETAILED REVIEW FOR SORAFENIB

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

ABSTRACT

Background: Sorafenib is a multi-kinase inhibitor used in the treatment of renal cell carcinoma, hepatocellular carcinoma, and thyroid cancer. Despite its efficacy, Sorafenib is prone to degradation under various stress conditions, which can affect its safety, efficacy, and stability. Understanding these degradation pathways is critical for developing robust formulations and ensuring regulatory compliance. Aim: This review aims to explore the degradation behavior of Sorafenib under different stress conditions, including acidic, basic, oxidative, thermal, and photolytic environments, and to analyze the implications for its stability and quality control. Research Methodology: A comprehensive literature review was conducted, focusing on forced degradation studies and their impact on Sorafenib. The research evaluated the degradation mechanisms, analytical techniques for identifying degradation products, and the stability profile of Sorafenib under various stress conditions. Conclusion: Sorafenib undergoes significant degradation under acidic, basic, oxidative, thermal, and photolytic conditions, leading to the formation of degradation products that can compromise its therapeutic efficacy. Stress testing, including chromatography and mass spectrometry, is essential for assessing and controlling these degradation pathways, ensuring the drug's safety and effectiveness in clinical use.

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