World Journal of
Pharmaceutical and Life Sciences

METHOD DEVELOPMENT AND VALIDATION OF SORAFENIB IN MARKET FORMULATION

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

ABSTRACT

Background: Sorafenib is a multi-kinase inhibitor widely used in oncology. Developing robust analytical methods
for its quantification ensures quality and efficacy in pharmaceutical formulations. Ultra-performance liquid
chromatography (UPLC) is an advanced technique offering high precision and sensitivity for such analyses. Aim:
This study aims to develop and validate a UPLC-based method for Sorafenib quantification, evaluating its
precision, accuracy, linearity, robustness, and ruggedness. Research Methodology: A UPLC system with a C18
stationary phase was utilized. Methanol and acetonitrile (55:45, %v/v) served as the mobile phase. UV detection
was performed at 240 nm with prednisolone as the internal standard. Retention times for Sorafenib and
prednisolone were 7.292 and 2.645 minutes, respectively. Validation studies adhered to ICH guidelines,
demonstrating recovery rates of 99.62–99.87%, a linearity coefficient of 0.9992, and a %RSD of 0.23% for
ruggedness. Conclusion: The developed UPLC method is accurate, precise, and reproducible, proving its utility for
routine quality control of Sorafenib in pharmaceutical formulations.

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