Development and validation of stability indicating rp-hplc method for the estimation of cabozantinib in pharmaceutical dosage form

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic (RPHPLC) method was developed for the estimation of Cabozantinib, using a reversed-phase C18 column (250 mm × 4.6 mm, 5 µm) a mobile phase consisting of 0.1% Formic acid:acetonitrile:methanol (35:33:32 v/v), at a flow rate of 1.0 mL/min and ultraviolet detection at 244 nm. The retention time of cabozantinib was found to be 6.03 min. Linearity was established in the range of 100- 500 μg/mL with correlation coefficients 0.990. The percentage recoveries of cabozantinib were found to be in the range of 99.59- 99.96%. Stress testing was carried out to demonstrate specificity of the method. The developed method could separate the potential degradation products from the cabozantinib. This proposed method was suitable for analysis the content of cabozantinib in tablet dosage form. The method is validated as per ICH guidelines.