Exploring RP-HPLC Method for analysis of Axitinib in Bulk and in-house Tablets

Axitinib is tyrosine kinase Inhibiter and an oral, selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 (Pithavala et al., 2012; Lakshmi et al., 2012). It is a small molecule developed by Pfizer. Axitinib is an indazole derivative, chemically it is N-Methyl-2 [[3-[(e) -2-pyridin-2-ylethyl-1H-indazole-6-yl]sulfanyl]benzamide. The molecular formula of Axitinib is C22H18N4OS and molecular weight is 386.46 gm/mol(Chandra and Sarada, 2016; Wilmes et al., 2007). It specifically restrains vascular endothelial development factor receptors (VEGFR-1, VEGFR-2, VEGFR-3); tumour development and metastases.1,2 Axitinib has been accounted to be 50450 times more potent than first generation VEGFR inhibitors(Bouchet et al., 2011). In Literature studies, few analytical methods for assessment of Axitinib have been studied, which includes liquid chromatography-mass spectrophotometry (LC-MS/ MS)(Lankheet et al., 2013; Sparidans et al., 2009; Gorja and Sumantha, 2017), UPLC(Chakravarthy et al., 2016), spectrophotometric(Panda et al., 2016) and HPLC (Chandra and Sarada, 2016; ICH, 2005). To our knowledge, till date no HPLC method has been reported for the assurance of Axitinib in bulk and in-house tablet dosage form. Therefore, an attempt of proposed work is toestablish a simple, reliable and reproducible RP-HPLC method for determination of Axitinib in bulk and in-house tablet dosage form. Also, an established method wasvalidated in accordance with ICH guidelines Q2(B).