Simultaneous Method Validation for the Estimation of Nivolumab and Cabozantinib in Bulk and Pharmaceutical Dosage Form by Rp-HPLC Method

Aim: The present study aimed to progress a modest, novel, and specific method for the simultaneous evaluation of Nivolumab and Cabozantinib in bulk and tablet dosage form by Reverse-phase high-performance liquid chromatography (RP-HPLC). Material and Methods: Nivolumab and Cabozantinib pure drugs (API), Combination Nivolumab and Cabozantinib Synthetic Formulation, Distilled water, Acetonitrile, Phosphate buffer, Methanol, Potassium dihydrogen ortho phosphate buffer, Ortho-phosphoric acid. All the above chemicals and solvents are from Rankem. Based on the solubility of the drugs, diluent was selected, Acetonitrile and H2O in the ratio of 50:50 v/v. Results: The method exhibited excellent precision with %RSD values of 0.7 for Nivolumab and 0.9 for Cabozantinib. Recovery studies revealed the method`s accuracy with recovery rates of 100.16% for Nivolumab and 99.63% for Cabozantinib. Limits of detection(LOD) and quantification(LOQ) were determined as 0.20 µg/mL, 0.03 µg/mL for Nivolumab and 0.61µg/mL,0.08 µg/mL for Cabozantinib. The regression equations obtained for Nivolumab and Cabozantinib were y =39306x + 12173 and y =34894x +1139.7 respectively. Conclusion: The benefit is in the ease of sample preparation and the cost-effective use of fewer chemicals and the precision and reproducibility of the experimental data are good, according to statistical analysis.