QBD APPROACH FOR METHOD DEVELOPMENT AND VALIDATION OF TIVOZANIB BULK DRUG AND IT'S FORMULATION BY USING RP-HPLC

Attempts were made to develop RP-HPLC method for estimation of Tivozanib from tablet. For the RP - HPLC Agilent (S.K) method Gradient System UV Detector and C18 column with 250mm x4.6 mm i.d and 5μm particle size methanol: Methanol+0.05% OPA (80+20% v/v) was used as the mobile phase for the method. The detection wavelength was 220 nm and flow rate was 0.8 ml/min. In the developed method, the retention time of Tivozanib were found to be 4.280 min.The developed method was validated according to the ICH guidelines.  The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. So, it is worthwhile that, the proposed methods can be successfully utilized for the routine quality control analysis Tivozanib in bulk drug as well as in formulations.

Keywords: Tivozanib, RP-HPLC, Chromatogram.