World Journal of
Pharmaceutical and Life Sciences

METHOD DEVELOPMENT AND VALIDATION OF SORAFENIB IN BULK FORMULATION

Osman Ahmed*, Alufa Tahreem and Anas Rasheed

ABSTRACT

Background: Sorafenib, an oral multi-kinase inhibitor, is extensively utilized in oncology for its antineoplastic properties. Accurate quantification of Sorafenib in pharmaceutical formulations is critical for quality control and therapeutic efficacy. Ultra-performance liquid chromatography (UPLC) offers a sensitive and efficient analytical method for such evaluations. Aim: This study aimed to develop and validate a precise and robust UPLC method for the quantification of Sorafenib, focusing on accuracy, precision, linearity, and robustness. Research Methodology: The method development employed UPLC with a C18 column as the stationary phase. The mobile phase consisted of methanol and acetonitrile in a 55:45 ratio (%v/v). Prednisolone was used as an internal standard. Validation studies encompassed accuracy, precision, linearity, robustness, and ruggedness. Results demonstrated distinct retention times for Sorafenib (7.289 minutes) and the internal standard (2.639 minutes), with excellent resolution and a clear baseline. Accuracy ranged from 99.62% to 99.87%, while the linearity coefficient was 0.9985. Conclusion: The validated UPLC method proved to be robust, precise, and reproducible, demonstrating its suitability for routine analysis of Sorafenib in pharmaceutical formulations.

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