METHOD DEVELOPMENT AND VALIDATION OF TIVOZANIB BY USING RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM
Keywords:Tivozanib, RP-HPLC, Development, Validation, ICH guidelines
Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredient of Tivozanib.
Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Tivozanib. The chromatographic strategy utilized X-bridge phenyl column of dimensions 150x4.6 mm, 3.5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent formic acid (50:50). A flow rate of 1 ml/min and a detector wavelength of 216 nm utilizing the PDA detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines.
Results: LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2 > 0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range.
Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drugs.
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