ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CABOZANTINIB & NIVOLUMAB IN COMBINED PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

A simple, accurate and precise HPLC method for simultaneous determination of Cabozantinib and Nivolumab in pure and tablet dosage form has been developed. HPLC of Waters (Model: Alliance 2695) with Phenomenax Luna C18(4.6 mm × 250 mm, 5 µm) column was used for chromatographic separation. Mobile phase consists of Methanol: Water (65:35% v/v) and flow rate adjusted was 1 ml/min. Wavelength selected for detection was 220 nm and injection volume was 10 µl. The method has been validated for linearity, accuracy, and precision. The linearity of Cabozantinib and Nivolumab were in the range of 30 μg/ml respectively. The developed HPLC method offers several advantages such as rapidity, usage of simple mobile phase and easy sample preparation steps. Further, improved sensitivity makes it specific and reliable for its intended use. Hence, this method can be applied for the analysis of pure drug and pharmaceutical dosage forms. From the present study it can be concluded that the proposed method is simple, sensitive, precise, specific, accurate and reproducible. Results of validation parameters demonstrated that the analytical procedure is suitable for its intended purpose and meets the criteria defined in ICH.