World Journal of
Pharmaceutical and Life Sciences

IMPURITY PROFILING AND RELATED SUBSTANCES STUDY OF SORAFENIB

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

ABSTRACT

Background: Sorafenib, a multi-kinase inhibitor, is widely utilized in oncology. Developing a validated analytical method is essential 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 and its related impurities in bulk and dosage forms under 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 conducted under acidic, basic, oxidative, wet heat, and photolytic conditions to evaluate method specificity and impurity profiling. Conclusion: The developed UPLC method demonstrated excellent resolution, allowing for effective impurity profiling and stability analysis of Sorafenib. The method proved precise, accurate, and robust, making it ideal for quality control and regulatory compliance in pharmaceutical formulations.

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