నైరూప్య

Development and Validation of Reverse Phase High Performance Liquid Chromatographic Method for Quantitative Estimation of Lenvatinib in Capsule Dosage Form

Priya Temgire

The aim of the work is to develop a simple, accurate, precise, and reproducible Reverse Phase High Performance Liquid Chromatographic (RP- HPLC) method for the determination of anticancer drug Lenvatinib in capsule dosage form. Chromatography was carried out on an Inert Sustain C18 (250 mm*4.6 mm*5 μm) column with a mobile phase consisting of Water : Acetonitrile : Trifluoroacetic acid (60:40:0.1) v/v. The detection was carried out at 241 nm, 10 μl injection volume was selected with a flow rate of 0.8 ml/min. Retention time was found to be 4.15 minutes. Method was linear over the range of 10-100 μg/ml with regression coefficient 0.9991. The method was validated as per ICH guidelines. The developed method is superior in terms of theoretical plates and it has got less tailing factor. The method can be applied for routine quality control analysis of Lenvatinib in capsule formulation.