METHOD DEVELOPMENT AND VALIDATION OF TIVOZANIB BY USING RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM

Authors

  • T. JAISON JOSE Department of Chemistry, Andhra Loyola College, Vijayawada, AP 520008, India
  • Y. SUBBAREDDY Department of Chemistry, Andhra Loyola College, Vijayawada, AP 520008, India
  • K. SANKAR Department of Botany, Andhra Loyola College, Vijayawada, AP 520008, India

DOI:

https://doi.org/10.22159/ijap.2021v13i6.42701

Keywords:

Tivozanib, RP-HPLC, Development, Validation, ICH guidelines

Abstract

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredient of Tivozanib.

Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Tivozanib. The chromatographic strategy utilized X-bridge phenyl column of dimensions 150x4.6 mm, 3.5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent formic acid (50:50). A flow rate of 1 ml/min and a detector wavelength of 216 nm utilizing the PDA detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines.

Results: LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2 > 0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range.

Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drugs.

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References

Van den Oever MC, Spijker S, Smit AB, De Vries TJ. Prefrontal cortex plasticity mechanisms in drug seeking and relapse. Neurosci Biobehav Rev 2010;35:276–84.

Hudson A, Stamp JA. Ovarian hormones and propensity to drug relapse: a review. Neurosci Biobehav Rev 2011;35:427–36.

Rini BI, Rathmell WK, Godley P. Renal cell carcinoma. Curr Opin Oncol 2008;20:300–6.

Quinn DI, Lara PN. Renal-Cell Cancer – Targeting an Immune Checkpoint or Multiple Kinases. N Engl J Med 2015;373:1872–4.

Ljungberg Borje, Campbell Steven C, Choi Han Yong, Jacqmin Didier, Lee Jung Eun, Weikert Steffen, Kiemeney Lambertus A. The Epidemiology of Renal Cell Carcinoma. Eur Urol 2011;60:615–21.

Levitzki A, Mishani E. Tyrphostins and other tyrosine kinase inhibitors. Annu Rev Biochem 2006;75:93–109.

Mills RJ, Young CA, Pallant JF, Tennant A. Development of a patient reported outcome scale for fatigue in multiple sclerosis: The Neurological Fatigue Index (NFI-MS). Health Qual Life Outcomes 2010;8:22.

Lackland DT, Weber MA. Global burden of cardiovascular disease and stroke: hypertension at the core. Can J Cardiol 2015;31:569–71.

Musini VM, Gueyffier F, Puil L, Salzwedel DM, Wright JM. Pharmacotherapy for hypertension in adults aged 18 to 59 years. Cochrane Database Syst Rev 2017;2017:CD008276.

Kaplan Randall J, Greenwood, Carol E. Influence of dietary carbohydrates and glycaemic response on subjective appetite and food intake in healthy elderly persons. Int J Food Sci Nutr 2002;53:305–316.

Van Houtte E, Van Lierde K, Claeys S. Pathophysiology and treatment of muscle tension dysphonia: a review of the current knowledge. J V 2011;25:202–7.

Pantalone KM, Hatipoglu BA. Hyponatremia and the Thyroid: Causality or Association? J Clin Med 2014;4:32–6.

Wiersinga WM, Duntas L, Fadeyev V, Nygaard B, Vanderpump MP. 2012 ETA Guidelines: The Use of L-T4 + L-T3 in the Treatment of Hypothyroidism. Eur Thyroid J 2012;1:55–71.

Goldsobel AB, Chipps BE. Cough in the pediatric population. J Pediatr 2010;156:352–8.

Fourie J, van Heerden WF, McEachen SC, van Zyl A. Chronic ulcerative stomatitis: a distinct clinical entity?. SADJ 2011;66:119–21.

ohnston DE (1999). Special considerations in interpreting liver function tests. Am Fam Physician 1999;59:2223–30.

Shivaraj Gowda, Prakash B Desai, Vinayak V Hull, Avinash AK Math, Sonal N, Venekar, Shruthi S, Kulkarni. A review on laboratory liver function tests. Pan Afr Med J 2009;3:17.

Cerrizuela, Santiago, Vega‐Lopez, Guillermo A, Aybar, Manuel J. The role of teratogens in neural crest development. Birth Defects Res 2020;112:584–632.

Bellinger DC. Teratogen update: lead and pregnancy. Birth Defects Res Clin Mol Teratol 2005;6: 409–20.

Qiu H, Mathas M, Nestler S, Bengel C, Nem D, Godtel-Armbrust U, et al. The unique complexity of the CYP3A4 upstream region suggests a nongenetic explanation of its expression variability. Pharmacogenet Genomics 2010;20:167–78.

Bishop-Bailey D, Thomson S, Askari A, Faulkner A, Wheeler-Jones C. Lipid-metabolizing CYPs in the regulation and dysregulation of metabolism. Annu Rev Nutr 2014;34:261–79.

Birbrair A, Zhang T, Wang ZM, Messi ML, Olson JD, Mintz A, Delbono O (July 2014). Type-2 pericytes participate in normal and tumoral angiogenesis. Am J Physiol Cell Physiol 307:C25-38.

McDougall SR, Anderson AR, Chaplain MA. Mathematical modelling of dynamic adaptive tumour-induced angiogenesis: clinical implications and therapeutic targeting strategies. J Theor Biol 2006;241:564–89.

Campas C, Bolos J, Castaner R. Tivozanib VEGFR Tyrosine Kinase Inhibitor Angiogenesis Inhibitor Oncolytic. Drugs of the Future 2009;34:793–6.

Karkkainen M J, Petrova T V. Vascular endothelial growth factor receptors in the regulation of angiogenesis and lymphangiogenesis. Oncogene 2000;19:5598–605.

Stuttfeld E, Ballmer-Hofer K. Structure and function of VEGF receptors. IUBMB Life 2009;61:915–22.

Zygmunt T, Gay CM, Blondelle J, Singh MK, Flaherty KM, Means PC et al. Semaphorin-PlexinD1 signaling limits angiogenic potential via the VEGF decoy receptor sFlt1. Deve Cell 2011;21:301–14.

Badal S, Delgoda R. Role of the modulation of CYP1A1 expression and activity in chemoprevention. J Appl Toxicol 2014;34:743–53.

Yang G, Ge S, Singh R, Basu S, Shatzer K, Zen M et al. Glucuronidation: driving factors and their impact on glucuronide disposition. Drug Metabolism Reviews 2017;49:105–138.

Cijo M Xavier, Kanakapura Basavaiah. RP-UPLC Development and validation of Metformin Hydrochloride in pure drug and pharmaceutical formulations. World journal of pharmacy and pharmaceutical sciences. 2015; 4: 1649-1668.

Sri Girija K, Bikshal Babu K, Venkateswara Rao A. A new high performance liquid chromatography method for the separation and simultaneous quantification of Eptifibatide and its impurities in pharmaceutical injection formulation. Int J App Pharm. 2021; 13: 165-172.

V L N Balaji Gupta T, Venkateswara Rao B, Kishore Babu B. RP-HPLC (stability indicating) based assay method for the simultaneous estimation of Doravirine, Tenofovir Disoproxil Fumarate and Lamivudine. Int J App Pharm. 2021; 13: 153-159.

Murali Krishnam Raju P, Venkata Narayana B, Shyamala P, Srinivasu K, H S N Raju D. A validated RP-HPLC method for impurity profiling of Sodium nitroprusside in injection dosage form. Int J App Pharm. 2021; 13: 160-169.

Sanathoiba Singha L, Srinivasa Rao T. Development and validation of an RP-HPLC method for the determination of Ulipristal acetate in pharmaceutical dosage form. Asian J Pharm Clin Res. 2021; 14: 83-89.

Asha Eluru, Surendra Babu K. A Study of Method Development, Validation and Forced Degradation for Simultaneous Quantification of Povidone Iodine and Ornidazole in Bulk and Pharmaceutical Dosage Form by Using RP-HPLC. Int J Res Pharm Sci 2021; 12: 1217-1222.

Malathi S, Devakumar D. Development and validation of rp-hplc method for the estimation of escitalopram oxalate and flupentixol dihydrochloride in combined dosage form and plasma. Int J Pharm Pharm Sci 2021; 13: 61-66.

Rafi S, Rambabu K. Stability indicating validated HPLC method for the determination of Aceclofenac and Misoprostol in bulk and pharmaceutical formulation. Int J Res Pharm Sci 2020; 11: 7848-7853.

Raviteja G, Rambabu K. A Study of Development and Validation of a Method for Simultaneous Estimation of Cidofovir and Famciclovir Using RP-HPLC. Int J Res Pharm Sci 2020; 11: 7878-7884.

Vijayakumari M, Balasekhar reddy Ch. Stability indicating validated hplc method for the determination of zanubrutinib in bulk and pharmaceutical dosage form. Asian J Pharm Clin Res 2020; 13: 159-62.

Charu Pandya P, Sadhana Rajput J. Development and validation of stability indicating method RP-HPLC method of Acotiamide. Int J Pharm Pharm Sci 2018; 10: 1-8.

Birva Athavia A, Zarna Dedania R et.al., Stability indicating HPLC method for determination of Vilazodone hydrochloride. Int J Curr Pharm Res 2017; 9: 123-9.

Published

26-08-2021

How to Cite

JOSE, T. J., SUBBAREDDY, Y., & SANKAR, K. (2021). METHOD DEVELOPMENT AND VALIDATION OF TIVOZANIB BY USING RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM. International Journal of Applied Pharmaceutics, 13(6). https://doi.org/10.22159/ijap.2021v13i6.42701

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