Exploring RP-HPLC Method for analysis of Axitinib in Bulk and in-house Tablets
Axitinib is a tyrosine kinase Inhibiter. In a commenced analysis, a effortless and responsive high-performance liquid-chromatography method was developed and validated for the quantitative estimation of Axitinib in bulk and in-house tablet dosage form. The present method was developed and validated using LC-GC Qualisil BDS C18 (250 mm × 4.6 mm, 5 μm). The separation of Axitinib was employed using a methanol: water 85:15% v/vas a mobile phase at optimal flow rate 1 mL/min and column oven temperature 30°C. While, Axitinib was examined at 330 nm with a photo diode array detector; retention timewas found to be 3.23 min.The intended method was validated by ICH rules for the accuracy, precision, sensitivity, and ruggedness. The linearity was followed in the concentration range of 4 - 24 μg/ mL as demonstrated by correlation coefficient (r2) of 0.9994. The robustness of proposed method was assessed by purposelyvarying the chromatographic conditions. Consequently, the intended method can routinely be subjected for th estimation of Axitinib in bulk and in tablets formulation.
2. Lakshmi, B., Saraswathi, K., Reddy, T. V., (2012). RPHPLC method development and validation for the analysis of Axitinib in pharmaceutical dosage forms. International Journal of Science Innovations and Discoveries, 2, 184–90.
3. Chandra, R. B. J. and Sarada, N. C. (2016). Development and validation of Stability indicating RP-HPLC method for the Determination of Axitinib in Bulk and its Pharmaceutical Formulations. Der Pharmacise Letter, 8(11), 97–106. https://www.drugbank.ca/drugs/DB06626
4. Wilmes, L. J., Pallavicini, M. G., Fleming, L. M., Gibbs, J., Wang, D., Li, K. L., Partridge, S. C., Henry, R. G., Shalinsky, D. R., Hu-Lowe, D., Park, J. W., McShane, T. M., Lu, Y., Brasch, R. C., Hylton, N. M. et al., (2007). A novel inhibitor of VEGF receptor tyrosine kinases, inhibits breast cancer growth and decreases vascular permeability as detected by dynamic contrast-enhanced magnetic resonance imaging. Magnetic Resonance Imaging, 25, 319–327. https://doi.org/10.1016/j.mri.2006.09.041
5. Bouchet, S., Chauzit, E., Ducint, D., Castaing, N., Canal-Raffin, M., Moore, N., Titier, K., Molimard, M., et al., (2011). Simultaneous determination of nine tyrosine kinase inhibitors by 96-well solid-phase extraction and Ultra Performance LC/MS-MS. Clinica Chimica Acta, 412, 1060–1067. https://doi.org/10.1016/j.cca.2011.02.023
6. Lankheet, N. A., Hillebrand, M. J., Rosing, H., Schellens, J. H., Beijnen, J. H. and Huitema, A. D., (2013). Method development and validation for the quantification of dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, sorafenib and sunitinib in human plasma by liquid chromatography coupled with tandem mass spectrometry. Biomedical chromatography, 27(4), 466–476. https://doi.org/10.1002/bmc.2814
7. Sparidans, R. W., Iusuf, D., Schinkel, A. H., Schellens, J. H., Beijnen, J. H. (2009). Liquid chromatographytandem mass spectrometric assay for the light sensitive tyrosine kinase inhibitor axitinib in human plasma. Journal of Chromatography B, 877(32), 4090–6. https://doi.org/10.1016/j.jchromb.2009.10.024
8. Gorja, A. and Sumantha, M., (2017). Development and validation of Stability indicating method for the estimation of Axitinib in tablet dosage form by UPLC. Indian Journal of Pharmaceutical and Biological Research, 5(3), 1–6.
9. Chakravarthy, V. A. and Sailaja, B. B. V., (2016). Method development and validation of UVspectroscopic method for the estimation of assay of anti-cancer drugs-axitinib, bosutinib, erlotinib hydrochloride, gefitinib and pemetrexed disodium drugs in api form. European Journal of Pharmaceutical and Medical Research, 3, 609–624.
10. Panda, S. S., Bera, V. V. R. K., Panda, N., (2016).Development and Validation of a Superior High Performance Liquid Chromatographic Method for Quantification of Axitinib in Solid Oral Dosage Form. American Journal of Modern Chromatography, 3, 33–43. https://doi.org/10.7726/ajmc.2016.1003
11. ICH Q2B (2005). Validation of analytical procedure; methodology, federal register. 1196(60), 27464.
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