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Analytical Method Development and Validation of Axitinib by RP-HPLC Method
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| Author:
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M BHARGAVA SAI, CHANDAN R S, BARATH M, DEVI SHRI CHIRIKI, ANAND KUMAR TENGLI
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| Abstract:
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Axitinib is a tyrosine kinase inhibitor of the second generation that selectively inhibits the endothelial vascular
growth factor. Axitinib inhibits angiogenesis, tumour progression and metastases by this mechanism of action.
It is stated that the strength of the first-generation VEGFR inhibitors is 50-450 times higher. Axitinib is a byproduct of indazole. These are most often sold using the name Inlyta as oral formulations. Therefore, an
accurate, fast, simple and cost-effective RP-HPLC technique for detecting Axitinib was developed. The RPHPLC method is developed by using 0.1 % Formic acid in MeOH and ACN 80:20 v/v as MP, the Flow rate is
maintained at 1 mL/minute. The column used for the analysis was Phenomenex luna C18 column (250mm X4.60
mm 5µ) and the column oven temperature was maintained at 25 ºC. Detection of Axitinib was performed by
using a UV detector at 255nm. The linearity range was 1- 32 µg/ml and the correlation coefficient was found to
be 0.9956. By this proposed method RT of Axitinib was identified at 2.6 min. The validation of the method
concerning system suitability, linearity, accuracy, precision, robustness and ruggedness according to ICH
guidelines.
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| Keyword:
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UV detector, RP-HPLC method, Axitinib, ICH Guidelines.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.125
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| Download:
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