Chitkara Open Access Journals - Blog

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


  • Shailesh S Chalikwar, Satish D Kayande and Atul A ShirkhedkarR.C. Patel Institute of Pharmaceutical Education and Research, Shirpur 425405 Dist. Dhule (MS), India
  • Inderbir SinghChitkara College of Pharmacy, Chitkara University, Rajpura 140401, Patiala Punjab, India


Axitinib, HPLC, validation, 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…



Pithavala, Y. K., Chen, Y., Toh, M., Selaru, P., Labadie, R. R., Garrett, M., Hee, B., Mount, J., Ni, G., Klamerus, K. J. and Tortorici, M. A. et al., (2012). Evaluation of the effect of food on the pharmacokinetics of axitinib in healthy volunteers. Cancer Chemotherapy and Pharmacology, 70(1), 103–112.

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.

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.

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.

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.

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.