NEW STABILITY-INDICATING ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION OF LENVATINIB MESYLATE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORMS
DOI:
https://doi.org/10.22159/ajpcr.2018.v11i9.26766Keywords:
Lenvatinib mesylate, Ultra performance liquid chromatography, Stability indicating, Method development, ValidationAbstract
Objective: The objective of the present study was to develop and validate a new stability-indicating method for the quantification of lenvatinib mesylate in bulk drug and pharmaceutical dosage form using ultra performance liquid chromatography (UPLC).
Methods: The optimized chromatographic conditions for elution of drug included UPLC HSS C18 (100 mm × 2.1 mm, 1.8 m) column, mixture of 0.1% orthophosphoric acid and acetonitrile (50:50 v/v%) mobile phase run on an isocratic mode at a flow rate of 0.3 mL/min, 240 nm detection wavelength, and column oven temperature maintained at 30°C.
Results: The retention time for lenvatinib was found to be 1.24 min. The developed method was validated for various validation parameters in accordance with the International Conference on Harmonization guidelines. The method obeyed Beer's law in the concentration range of 2.5– 15 μg/mL with a correlation coefficient of 0.9996. The percentage relative standard deviation and percentage recovery were determined to be 0.4 and 99.66–100.30%, respectively. The developed method was found to be accurate, precise, specific, linear, rugged, and robust. Forced degradation studies were conducted by exposing the drug to diverse stress conditions such as acidic, basic, peroxide, neutral, photolytic, and thermal conditions. The net degradation was obtained within the limits.
Conclusion: The developed method for the estimation of lenvatinib can be employed to routine analysis of pharmaceutical dosage form.
Downloads
References
Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med 2015;372:621-30.
Cabanillas ME, Schlumberger M, Jarzab B, Martins RG, Pacini F, Robinson B, et al. A phase 2 trial of lenvatinib (E7080) in advanced, progressive, radioiodine-refractory, differentiated thyroid cancer: A clinical outcomes and biomarker assessment. Cancer 2015;121:2749 56.
Krajewska J, Kukulska A, Jarzab B. Drug safety evaluation of lenvatinib for thyroid cancer. Expert Opin Drug Saf 2015;14:1935-43.
Cabanillas ME, Habra MA. Lenvatinib: Role in thyroid cancer and other solid tumors. Cancer Treat Rev 2016;42:47-55.
Matsui J, Funahashi Y, Uenaka T, Watanabe T, Tsuruoka A, Asada M. Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumor MDA-MB-231 via inhibition of vascular endothelial growth factor-receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res 2008;14:5459-65.
Krishnaphanisri P, Raja S. Development and validation of new RP-UPLC method for the determination of Cefdinir in bulk and dosage form. Int J Pharm Pharm Sci 2018;10:178-84.
Chakravarthy VA, Sailaja BB, Kumar AP. Development and validation of a dissolution method for frovatriptan tablets by reversed phase UPLC. Int J Pharm Pharm Sci 2015;7:125-30.
Mule KL. Rapid analytical method for assay determination for prochlorperazine edisylate drug substances by ultra performance liquid chromatography. Int J Curr Pharm Res 2017;9:118-22.
Prashanthi Y, Ahmed MA, Vijaya K, Riyazuddin Md. Method development and validation of lenvatinib drug by RP-HPLC in pharmaceutical drug dosage form. Indo Am J Pharm Sci 2016;3:1078-85.
Panigrahy UP, Reddy AS. A novel validated RP-HPLC-DAD method for the estimation of lenvatinib mesylate in bulk and pharmaceutical dosage form. J Chem Pharm Res 2015;7:872-81.
Shaikh A. Method development and validation of lenvatinib by HPLC and UV-Spectroscopy. Indian Drugs 2018;55:39-47.
Srikanth I, Rani AP. Development and validation of liquid chromatography coupled with tandem mass spectrometry method for estimation of lenvatinib in human plasma. Asian J Pharm Clin Res 2017;10:120-6.
Ogawa-Morita T, Sano Y, Okano T, Fujii H, Tahara M, Yamaguchi M, et al. Validation of a liquid chromatography-tandem mass spectrometric assay for quantitative analysis of lenvatinib in human plasma. Int J Anal Chem 2017;2017:1-6.
Mano Y, Kusano K. A validated LC–MS/MS method of total and unbound lenvatinib quantification in human serum for protein binding studies by equilibrium dialysis. J Pharm Biomed Anal 2015;114:82-7.
ICH. ICH: Q2 (R1), Validation of Analytical Procedures: Text and Methodology; 2005.
Bandla J, Ganapaty S. Stability indicating UPLC method development and validation for the determination of crizotinib in pharmaceutical dosage forms. Int J Pharm Sci Res 2018;9:1000-6.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.
