Vol. 6, Issue 1, Part A (2024)

A new method was established for estimation of Lenvatinib by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Lenvatinib by using thermosil C18 4.5×150 mm 5.0 µm, flow rate was 0.8ml/min, and mobile phase ratio was 65:35% v/v methanol: water, detection wavelength was 265nm. The instrument used was waters HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 4.35 mins. The% purity of Lenvatinib was found to be 99.87%. The system suitability parameters for Lenvatinib such as theoretical plates and tailing factor were found to be 4146, 1.23, the resolution was found to be 5.67. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Lenvatinib was found in concentration range of 30µg-150µg and correlation coefficient (r2) was found to be 0.999,% recovery was found to be 100.4%,%RSD for repeatability was 0.5,% RSD for intermediate precision was 1.0. The precision study was precision, robustness and repeatability. LOD value was 2.97 and LOQ value was 9.92 Hence the suggested RPHPLC method can be used for routine analysis of Lenvatinib in API and Pharmaceutical dosage form.