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METHOD DEVELOPMENT AND VALIDATION OF TIVOZANIB BY RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Journal: International Journal of Advanced Research (Vol.11, No. 08)

Publication Date:

Authors : ; ;

Page : 566-573

Keywords : Tivozanib RP-HPLC and ICH Guidelines Method Development;

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Abstract

The estimation of Tivozanib by RP-HPLC methodology was established using a simple, concise, and accurate method. Use of stationary Discovery C18 150mm x 4.6 mm, 5.mm, mobile phase 0.1% chromatographic conditions Orthophosphoric acid was mixed with acetonitrile in a 50:50 ratio, with a flow rate of 1.0 ml/min, a detection wavelength of 320 nm, a column temperature of 30 Oc, and mobile phase as the diluent. A retention time of 2.702 minutes was discovered. The standard was injected six times to study system suitability parameters, and the findings fell far short of the threshold for acceptance. An analysis of linearity between levels of 25% and 150% revealed an R2 value of 0.999. Precision for the Method was found to be 0.8, 0.6, and 0.9 for medium level of accuracy. 0.05 g/ml and 0.16 g/ml, respectively, are the LOD and LOQ. The assay of a commercial formulation was conducted using the procedure and 100.10% was found. Studies on the degradation of tivozanib were conducted, and under every circumstance, the purity threshold was higher than the purity angle and within the acceptable range. Even though the complete approach has not been tested yet, it can be used in order to do further analysis of Tivozanib routinely.

Last modified: 2023-10-03 19:46:09