METHOD DEVELOPMENT AND VALIDATION OF LENVATINIB BY HPLC AND UV-SPECTROSCOPY

A simple rapid, accurate, precise and reproducible validated UV spectroscopy, RP-HPLC method was were developed for the determination of lenvatinib in bulk forms. The quantification was carried out using HiQSil 4.6 X 250 mm, 5μ, C8 column, run in isocratic way using mobile phase comprising of methanol: ammonium acetate buffer 30:70 by volume, pH-3.5 adjusted with orthophosphoric acid and a detection wavelength of 301mm, and injection volume of 20μL, with a flow rate of 1.0mL/min. The retention time of lenvatinib was found to be 4.383 min., the linearity range of the proposed method lies between 10-40 μg/mL (r²=0.9992). recovery studies were also carried out and mean % recovery was found to be 99.05 for lenvatinib. LOD and LOQ values for lenvatinib were found to be 0.992 and 2.79 respectively. The proposed method was statistically evaluated and may be applied for routine quality control analysis of lenvatinib in bulk.