STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTIFICATION OF SORAFENIB AND REGORAFENIB DRUG SUBTANCES BY USING RP-UPLC

Abstract

Objective: The aim of the research work is to develop and validate a novel, sensitive, specific, rapid, accurate, precise and stability indicating gradient reverse phase ultra-performance liquid chromatography (RP-UPLC) method for the quantitative determination of sorafenib and regorafenib drug substances.
 Methods: Liquid chromatographic method used for the analysis of the anti-cancer drug substances like sorafenib and regorafenib and method was developed and validated by using efficient chromatographic separation method and was achieved with the use of acquity UPLC system was used consisting of quaternary pump, photodiode array detector an auto injector and on line degasser.
 Results: The separation was achieved using acquity UPLC BEH C18, 1.7 µm.2.1×50 mm analytical column at 30 °C employing a gradient elution. Empower software was used for data acquisition. During method validation all the parameters were evaluated as per ICH guidelines, which remained well within acceptable limits. Degradation of the drug substances was found to be stable to acidic, aqueous, basic hydrolysis, thermal hydrolysis and photolytic stress condition and the tests solution of the drug substance was found to be stable up to 24 h.
 Conclusion: The results of linearity, precision accuracy and specificity were proved to be within the limits. This method can be employed in routine analysis for simultaneous estimation of sorafenib andregorafenib drug substances in quality formulations and dissolution studies.