World Journal of
Pharmaceutical and Life Sciences

FORCE DEGRADATION METHOD DEVELOPMENT AND VALIDATION OF SORAFENIB IN MARKET FORMULATION

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

ABSTRACT

Background: Sorafenib, a multi-kinase inhibitor, is widely used in oncology. A robust and validated analytical method is critical for ensuring its quality and stability in pharmaceutical formulations. Aim: To develop and validate a stability-indicating UPLC method for the quantitative analysis of Sorafenib in bulk and dosage forms under various stress conditions. Research Methodology: The study employed a Waters UPLC system with a C18 stationary phase, methanol:acetonitrile (55:45 v/v) as the mobile phase, and UV detection at 240 nm. The method was validated for precision, accuracy, linearity, robustness, ruggedness, and specificity. Forced degradation studies were performed under acidic, basic, oxidative, wet heat, and photolytic conditions to assess method specificity. Conclusion: The developed UPLC method demonstrated excellent baseline separation with clear resolution for Sorafenib and its degradation products. The method proved to be precise, accurate, and robust, making it suitable for quality control and stability studies in pharmaceutical formulations.

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