RP-HPLC Method Development and Validation for The Analysis of Pharmaceutical Drug - AXITINIB
Keywords:
AXITINIB, Method Development, Validation, 254nm, 3.0min.Abstract
A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of AXITINIB. Isocratic elution at a flow rate of 1.2 ml /min was employed on a symmetry C18 column at ambient temperature. The mobile phase consisted of Acetonitrile : 0.1M Acetic Acid 50:50 (v/v). The UV detection wavelength was at 254 nm. Linearity was observed in concentration range of 10-50 ppm. The retention time for AXITINIB was 3.0 min. The method was validated as per the ICH guidelines. The proposed method can be successfully applied for the estimation of AXITINIB.
References
- "Inlyta (axitinib) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Retrieved 25 January 2014.
- Wilmes, LJ; Pallavicini, MG; Fleming, LM; Gibbs, J; Wang, D; Li, KL; Partridge, SC; Henry, RG; Shalinsky, DR; Hu-Lowe, D; Park, JW; McShane, TM; Lu, Y; Brasch, RC; Hylton, NM (April 2007). "AG-013736, 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 (3): 319–27. doi:10.1016/j.mri.2006.09.041. PMID 17371720.
- Rini, B; Rixe, O; Bukowski, R; Michaelson, MD; Wilding, G; Hudes, G; Bolte, O; Steinfeldt, H; Reich, SD; Motzer, R (June 2005). "AG-013736, a multi-target tyrosine kinase receptor inhibitor, demonstrates anti-tumor activity in a Phase 2 study of cytokine-refractory, metastatic renal cell cancer (RCC)". Journal of Clinical Oncology ASCO Annual Meeting Proceedings. 23 (16S): 4509.
- Rugo, HS; Herbst, RS; Liu, G; Park, JW; Kies, MS; Steinfeldt, HM; Pithavala, YK; Reich, SD; Freddo, JL; Wilding, G (August 2005). "Phase I trial of the oral antiangiogenesis agent AG-013736 in patients with advanced solid tumors: pharmacokinetic and clinical results"(PDF). Journal of Clinical Oncology. 23 (24): 5474–83. doi:10.1200/JCO.2005.04.192. PMID 16027439.
- "FDA Approves Inlyta for Advanced Renal Cell Carcinoma". Drugs.com. January 27, 2012.
- John Fauber; Elbert Chu (Oct 27, 2014). "The Slippery Slope: Is a Surrogate Endpoint Evidence of Efficacy?". Milwaukee Journal Sentinel/MedPage Today
- V. Ashok Chakravarthy and B. B. V. Sailaja, “Method development and validation of uv-visible spectroscopic method for the estimation of assay of anti cancer drugs- axitinib, bosutinib, erlotinib hydrochloride, gefitinib and pemetrexed disodium drugs in api form”. ejpmr, 2016,3(12), 609-624 ISSN 2394-3211
- B. Jala Chandra Reddy and N. C. Sarada, “Development and validation of Stability Indicating RP-HPLC Method for the Determination of Axitinib in Bulk and its Pharmaceutical Formulations”, Scholars Research Library Der Pharmacia Lettre, 2016, 8 (11):97-106 ISSN 0975-5071
- Sagar Suman Panda , Venkata Varaha Ravi Kumar Bera, and Niranjan Panda,“Development and Validation of a Superior High Performance Liquid Chromatographic Method for Quantification of Axitinib in Solid Oral Dosage Form”,Columbia International Publishing American Journal of Modern Chromatography (2016) Vol. 3 No. 1 pp. 33-43 doi:10.7726/ajmc.2016.1003
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