DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING ASSAY METHOD FOR ESTIMATION OF SORAFENIB TOSYLATE IN PURE AND PHARMACEUTICAL DOSAGE FORM BY HPTLC
Saroja P. Adepawar* and Shailaja B. Jadhav
A simple, specific and rapid validated stability indicating HPTLC method has been developed for estimation of Sorafenib Tosylate in bulk and pharmaceutical dosage form. The separation was carried out on Merck TLC aluminium sheets precoated with silica gel 60F254 were used for chromatographic separation. Combination of toluene: ethyl acetate (3:7 v/v) was selected as the mobile phase. Detection was done by UV absorbance mode at wavelength 265nm. Sorafenib Tosylate showed well defined and sharp peak at Rf 0.45 ± 0.02. The calibration curve of drug was found linear in the concentration range 200–1000 ng/band for Sorafenib Tosylate. The developed method was precise, robust and the % RSD was found less than 2%. Stress degradation study includes acid and base hydrolysis, oxidation, thermal and photolytic stress conditions in accordance with International Conference on Harmonization (ICH) guidelines Q1 (R2). The proposed method can be used for routine quality control analysis of bulk drug and marketed formulation containing Sorafenib Tosylate.
Keywords: Sorafenib Tosylate, HPTLC, Validation, Stability.
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