Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LOPINAVIR AND RITONAVIR BY RP-HPLC

J. Nagaraja*, Dr. M. Prasad Rao and K. Tirumula Devi

ABSTRACT

A reverse phase liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the determination of Lopinavir and Ritonavir in Bulk and its pharmaceutical formulation. Separation was achieved with a cosmosil C18, 250mm x4.6mm I.D; particle size 5 μm) Column and Water and Acetonitrile (50:50) v/v as mobile phase at a flow rate of 2.0 mL/min and the Column temperature was maintained at 25°C. UV detection was performed at 252.5 nm and sample temperature was maintained at 5°C with a run time of 15min. The method is simple, rapid, and selective. The described method of Lopinavir and Ritonavir is linear over a range of 200 μg/mL to 600 μg/mL and 50 μg/mL to 150 μg/mL with correlation coefficient of 0.999, 0.999 respectively for both lopinavir and ritonavir. The method precision for the determination of assay was below 2.0% RSD. The method enables accurate, precise, and rapid analysis of Lopinavir and Ritonavir. It can be conveniently adopted for routine quality control analysis of Bulk and pharmaceutical formulations.

Keywords: Lopinavir and Ritonavir, RP-HPLC, Method validation.