ICH Guidelines Analytical Method Development and Validation of Ipilimumab Injectable Formulation by Using Rp-UPLC

Abstract

A simple, Accurate, precise method was developed for the estimation of the Ipilimumab in bulk and pharmaceutical dosage form. Chromatogram was run through Acquity UPLC HSS C18 (100 x 1.8 mm, 2 µm). Mobile phase containing 0.01N KH2PO4: Acetonitrile taken in the ratio 55%v/v and 45%V/V was pumped through column at a flow rate of 0.31 ml/min. Temperature was maintained at 31.6°C. Optimized wavelength selected was ACQUITY TUV ChA 290.0 nm. Retention time of Ipilimumab was found to be 0.885 min. %RSD of the Ipilimumab was found to be 0.7. %Recovery was obtained as 100.23% for Ipilimumab. Regression equation of Ipilimumab is y = 33572x + 4077.4. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.