AQbD analytical Method Development and Validation of Ramucirumab in Bulk and Injectable Dosage form by Using RP-UPLC

A straight forward and precise method was developed to accurately estimate the percentage of Ramucirumab in both bulk and pharmaceutical dosage forms. The chromatogram was processed using the Acquity UPLC HSS C18 column, which has dimensions of 100 x 1.8 mm and a particle size of 2 µm. The column was pumped with a mobile phase consisting of 0.01N Na2HPo4 and methanol in a ratio of 61.5%v/v and 38.5%v/v, respectively, at a flow rate of 0.29 ml/min. The temperature was consistently maintained at 30.7°C. The chosen wavelength for optimization was ACQUITY TUV ChA 320.0 nm. The retention time of Ramucirumab was determined to be 1.469 minutes. The relative standard deviation (RSD) of Ramucirumab was determined to be 0.6%. The recovery rate for Ramucirumab was measured to be 99.79%. The regression equation for Ramucirumab is expressed as y = 16457x + 6948.2. The retention times and run time were reduced, making the developed method simple and cost-effective for regular quality control tests in industries.