METHOD DEVELOPMENT AND VALIDATION OF LENVATINIB DRUG BY RP-HPLC IN PHARMACEUTICAL DRUG DOSAGE FORM

A novel approach has used for the development and validates a rapid, simple and an isocratic RP-HPLC method with PDA detector for the estimation of Lenvatinib drug in pharmaceutical drug dosage form. Lenvatinib was separated using YMC C 18, 4.6 X 150 mm, 5 µ analytical column, a Waters HPLC system and a mobile phase consists of water and methanol in the ratio of 30:70 % v/v, delivered at 0.6 ml/min with 20 µl injection volume. The detector wavelength was at 240 nm. The system suitability parameters for Lenvatinib drug such as theoretical plates and tailing factor were found to be 4384.4, 1.6 respectively. Linearity was established for Lenvatinib in the range of 20 – 100 µg/ml concentration levels with a correlation coefficient of (r2) 0.999. The repeatability and reproducibility precision values were found to be 0.75 and 0.31 % respectively. The accuracy values were found to be in the range of 98 – 102 %. The limits of detection and quantification values were 0.48 µg/ml and 1.46 µg/ml respectively. The method was validated for specificity, system suitability, precision, accuracy, LOD and LOQ parameters as per the ICH guidelines. This method can be used for the estimation and analysis of Lenvatinib drug in active pharmaceutical ingredients and pharmaceuticals.Keywords: Lenvatinib, Lenvima, High Performance Liquid Chromatography, Photo Diode Array detector, Estimatio