ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF NIVOLUMAB AND RELATLIMAB IN PHARMACEUTICALS DOSAGE FORM BY HPLC

Abstract

The pharmaceutical dosage forms of the immunotherapy treatment medicine Nivolumab and Relatlimab were identified using high-performance liquid chromatography (HPLC). A 150 x 4.6 mm Agilent C 18 column with a particle size of 5μm was utilized. Sixty percent ammonium acetate buffer and forty percent acetonitrile make up the mobile phase. A wavelength of 221 nm was identified. Nivolumab had a retention of 2.245 minutes and Relatlimab of 2.736 minutes. The relative standard deviations of the two medications were 0.5% and 0.3%, respectively; the regression lines for the two drugs were y = 76535x + 17268 and y = 78171x + 5761.7, and the Assay results for each drug were 99.64% and 99.91%, respectively. All the other metrics were verified and monitored within the specified ranges