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Determination of Potential Genotoxic Impurities in Sorafenib Tosylate by UPLC Method
Authors: Ravi R. Yadav, Manoj D. Rokade, Deepali M. Gangrade, Ganesh S. Holkar, Vinayak N. Daphal and Motiram Patil
Number of views: 527
ABSTRACTS: An isocratic reversed-phase UPLC method with UV detector has been developed for the
determination of Methyl Tosylate, Ethyl Tosylate and Isopropyl Tosylate in Sorafenib Tosylate. These are
potential genotoxic impurities and hence need to be controlled in Sorafenib Tosylate. The analysis was
performed using RRHD Eclipsed Plus C18 UPLC column (50 x 2.1mm, 1.8μm) as a stationary phase with
column oven temperature 40°C, and UV detection at 226nm. The separation was achieved using mobile phase
comprising of 50mM Sodium Perchlorate in water and pH adjusted to 3.0 with glacial acetic acid and
Acetonitrile in the volume ratio of 60.0:40.0. The method was optimized based on the peak shapes and
resolution between Methyl Tosylate, ethyl Tosylate, propyl Tosylate and Sorafenib Tosylate. The method was
validated as per International Conference of Harmonization (ICH) guidelines in terms of limit of detection
(LOD), Limit of quantitation (LOQ), linearity, precision, accuracy, specificity, robustness and solution
stability. The LOD and LOQ values were found to be 0.045μg/ml and 0.09μg/ml, respectively. The sample
concentration were injected was 15mg/ml. The method is linear within the range of 0.09-0.3μg/ml for both the
Impurities.