World Journal of
Pharmaceutical and Life Sciences

FORCE DEGRADATION METHOD DEVELOPMENT AND VALIDATION OF SORAFENIB IN BULK FORMULATION

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

ABSTRACT

Background: Sorafenib is an essential therapeutic agent used in treating hepatocellular and renal cell carcinoma. The development of a precise, accurate, and robust UPLC method for its quantification ensures consistency in pharmaceutical formulations and enhances its therapeutic efficacy. Aim: To develop and validate a UPLC method for Sorafenib estimation, incorporating validation parameters such as accuracy, precision, linearity, robustness, ruggedness, and forced degradation studies. Research Methodology: The UPLC system with a C18 stationary phase was employed using methanol and acetonitrile (55:45% v/v) as the mobile phase, and prednisolone as the internal standard. Sorafenib's retention time was 7.289 minutes, with UV detection at 240 nm. Validation studies evaluated system precision, linearity, accuracy (mean recovery 99.74%), robustness, and ruggedness. Forced degradation under acidic, basic, oxidative, thermal, and photolytic conditions demonstrated the method's specificity. Conclusion: The developed UPLC method offers superior resolution, reliability, and sensitivity for Sorafenib quantification, meeting ICH guidelines. This robust analytical tool facilitates quality control in pharmaceutical formulations.

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