Simultaneous Method Development and Validation For Estimation of Nivolumab and Cabozantinib In Bulk and Pharmaceutical Dosage Form by RP-HPLC Method

A simple, precise, and accurate method was developed for the simultaneous estimation of Nivolumab (NVM) and Cabozantinib (CBZ) in tablet dosage form.  The chromatogram was analyzed through a Phenomenex C18 150 mm (4.6 x 150 mm, 5 m) for chromatogram processing. A mobile phase containing formic acid: methanol (50:50) was pumped through the column at a spurge flow of 1.0 mL/min.  The column temperature was upheld at 30°C.  The quantification was done at 260.0 nm.  The elution time of NVM and CBZ was found to be 2.243 min and 2.953 min, respectively. The validation for the developed method was performed and all the parameters were found within the specified limits. The standard curve results represent a correlation coefficient of more than 0.999.  The %RSD of NVM and CBZ were found to be 0.9 and 0.7, respectively.  % Recovery was achieved as 99.88% and 99.66% for NVB and CBZ, respectively. The NVM and CBZ regression equations yielded LOD and LOQ values of 0.63, 1.91, and 0.08, 0.24 respectively. The equation of Nivolumab y is 39306x + 12173 while the Cabozantinib y is 34894x + 1139.7. With all the parameters under the criteria, the developed method for the simultaneous estimation of Nivolumab and Cabozantinib can be successfully applied for regular quality control approaches.