Analytical method development and validation for the simultaneous estimation of nivolumab and relatlimab in its bulk and pharmaceutical dosage form.
Keywords:
Relatlimab, Nivolumab, RP-HPLC, Validation, PrecisionAbstract
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Relatlimab and Nivolumab, in its pure form as well as in tablet dosage form. Chromatography was carried out on X bridge C18 (4.6×150mm) 5µcolumn using a mixture of Methanol: Phosphate Buffer pH3 (60:40v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 260nm. The retention time of the Relatlimab and Nivolumab was 2.6, 3.8±0.02min respectively. The method produce linear responses in the concentration range of 5-25µg/ml of Relatlimab and 20-100µg/ml of Nivolumab respectively. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.