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Drug Metabolism and Bioanalysis Letters

Editor-in-Chief

ISSN (Print): 2949-6810
ISSN (Online): 2949-6829

Research Article

Rapid, Simple and Low-Cost Analytical Method Development for Quantification of Eltrombopag Olamine in Tablet Dosage by UV Spectroscopy Method

Author(s): Nandan Godani and Sanjay Sharma*

Volume 17, Issue 1, 2024

Published on: 16 April, 2024

Page: [42 - 48] Pages: 7

DOI: 10.2174/0118723128289305240404070703

Price: $65

Abstract

Background: Eltrombopag Olamine is a drug used to treat thrombocytopenia, a disorder where blood platelet counts get lower and severe aplastic anemia. It serves as a thrombopoietin receptor agonist, which give rise to platelet production in the bone marrow.

Objectives: The objective of this study is to develop a simple, specific, accurate, precise and economical Ultraviolet spectroscopy method to estimate the amount of Eltrombopag Olamine in bulk and tablet dosage form.

Methods: The developed method was performed using methanol for identification and physicochemical characterization of the drug. The validation parameters like linearity, precision, accuracy, robustness limits of detection and quantitation, and specificity were assessed as per ICH Q2 (R2).

Results: The maximum absorbance wavelength (λmax) of the drug was found at 247 nm in methanol. The linearity was found in the concentration range of 2-14 μg/ml with regression equation y = 0.0619x - 0.0123 and r² = 0.999. The standard addition method was used to determine the accuracy of the developed method. The result was found in the % recovery range of 98-99%. The precision was done on λmax with respect to the parameters such as repeatability, intraday, and interday. The method was found to be precise as the % RSD value was found to be <2%. The detection limit value (LOD) and quantitation limit value (LOQ) were 0.0524 μg/ml and 0.1588 μg/ml, respectively.

Conclusion: The developed method is simple, economical, accurate and selective. The developed method was adaptable for the estimation of Eltrombopag Olamine analysis in pharmaceutical dosage form and routine quality control laboratory.

Graphical Abstract

[1]
Kashiwagi, H.; Tomiyama, Y. Pathophysiology and management of primary immune thrombocytopenia. Int. J. Hematol., 2013, 98(1), 24-33.
[http://dx.doi.org/10.1007/s12185-013-1370-4] [PMID: 23702914]
[2]
Rodeghiero, F.; Stasi, R.; Gernsheimer, T.; Michel, M.; Provan, D.; Arnold, D.M.; Bussel, J.B.; Cines, D.B.; Chong, B.H.; Cooper, N.; Godeau, B.; Lechner, K.; Mazzucconi, M.G.; McMillan, R.; Sanz, M.A.; Imbach, P.; Blanchette, V.; Kühne, T.; Ruggeri, M.; George, J.N. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: Report from an international working group. Blood, 2009, 113(11), 2386-2393.
[http://dx.doi.org/10.1182/blood-2008-07-162503] [PMID: 19005182]
[3]
Vaillant, A.A.J.; Gupta, N. ITP-Immune thrombocytopenic purpura. In: StatPearls; StatPearls Publishing: Treasure Island (FL), 2023.
[4]
Cheng, G. Eltrombopag, a thrombopoietin-receptor agonist in the treatment of adult chronic immune thrombocytopenia: A review of the efficacy and safety profile. Ther. Adv. Hematol., 2012, 3(3), 155-164.
[http://dx.doi.org/10.1177/2040620712442525] [PMID: 23556122]
[5]
Gonzalez-Porras, J.R.; Bastida, J.M. Eltrombopag in immune thrombocytopenia: Efficacy review and update on drug safety. Ther. Adv. Drug Saf., 2018, 9(6), 263-285.
[http://dx.doi.org/10.1177/2042098618769587] [PMID: 29854389]
[6]
Lambert, M.P.; Gernsheimer, T.B. Clinical updates in adult immune thrombocytopenia. Blood, 2017, 129(21), 2829-2835.
[http://dx.doi.org/10.1182/blood-2017-03-754119] [PMID: 28416506]
[7]
Palandri, F.; Polverelli, N.; Sollazzo, D.; Romano, M.; Catani, L.; Cavo, M.; Vianelli, N. Have splenectomy rate and main outcomes of ITP changed after the introduction of new treatments? A monocentric study in the outpatient setting during 35 years. Am. J. Hematol., 2016, 91(4), E267-E272.
[http://dx.doi.org/10.1002/ajh.24310] [PMID: 26799593]
[8]
Kim, T.O.; Despotovic, J.; Lambert, M.P. Eltrombopag for use in children with immune thrombocytopenia. Blood Adv., 2018, 2(4), 454-461.
[http://dx.doi.org/10.1182/bloodadvances.2017010660 ] [PMID: 29487060]
[9]
Mihăilă R.G.; Cipăian, R.C. Eltrombopag in chronic hepatitis C. World J. Gastroenterol., 2014, 20(35), 12517-12521.
[http://dx.doi.org/10.3748/wjg.v20.i35.12517] [PMID: 25253952]
[10]
Danish, F.A.; Yasmin, S. The role of eltrombopag in the management of hepatitis C virus-related thrombocytopenia. Hepat. Med., 2013, 5, 17-30.
[http://dx.doi.org/10.2147/HMER.S27100] [PMID: 24696622]
[11]
Stasi, R.; Evangelista, M.L.; Amadori, S. Novel thrombopoietic agents: A review of their use in idiopathic thrombocytopenic purpura. Drugs, 2008, 68(7), 901-912.
[http://dx.doi.org/10.2165/00003495-200868070-00002 ] [PMID: 18457458]
[12]
Stasi, R. Eltrombopag for the treatment of idiopathic thrombocytopenic purpura. Expert Rev. Hematol., 2008, 1(2), 145-152.
[http://dx.doi.org/10.1586/17474086.1.2.145] [PMID: 21082919]
[13]
Deng, Y.; Madatian, A.; Wire, M.B.; Bowen, C.; Park, J.W.; Williams, D.; Peng, B.; Schubert, E.; Gorycki, F.; Levy, M.; Gorycki, P.D. Metabolism and disposition of eltrombopag, an oral, nonpeptide thrombopoietin receptor agonist, in healthy human subjects. Drug Metab. Dispos., 2011, 39(9), 1734-1746.
[http://dx.doi.org/10.1124/dmd.111.040170] [PMID: 21646437]
[14]
Takeuchi, K.; Sugiura, T.; Umeda, S.; Matsubara, K.; Horikawa, M.; Nakamichi, N.; Silver, D.L.; Ishiwata, N.; Kato, Y. Pharmacokinetics and hepatic uptake of eltrombopag, a novel platelet-increasing agent. Drug Metab. Dispos., 2011, 39(6), 1088-1096.
[http://dx.doi.org/10.1124/dmd.110.037960] [PMID: 21422191]
[15]
DailyMed - PROMACTA-eltrombopag olamine tablet, film coated PROMACTA-eltrombopag olamine powder, for suspension. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7714a0ed-34bb-46e6-a0a5-b363908b22c2
[16]
Qu, H.; Wu, J.; Ma, C.; Qiaolongbatu, X.; Song, X.; Feng, T.; Wu, Z.; Lou, Y.; Fan, G. Safety profile of eltrombopag in different age groups: An analysis of REAL‐WORLD pharmacovigilance and randomized clinical trials. Clin. Pharmacol. Ther., 2023, 114(1), 201-210.
[http://dx.doi.org/10.1002/cpt.2918] [PMID: 37087633]
[17]
Eltrombopag olamine | C29H36N6O6 | CID 135449331 - PubChem. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/135449331
[18]
Eltrombopag olamine | DrugBank Online. Available from: https://go.drugbank.com/salts/DBSALT000063
[19]
Dandabattina, R.; Subramanian, V.B.; Merugu, K.S. SharathBabu, H.; Katari, N.K.; Kowtharapu, L.P. Stability-indicating RP-HPLC method development and validation for eltrombopag olamine in the presence of impurities and degradation products. Robustness by design of expert software. J. AOAC Int., 2023, 106(2), 267-275.
[http://dx.doi.org/10.1093/jaoacint/qsac153 ] [PMID: 36416121]
[20]
Jayagopal, B.; Murugesh, S. QBD-driven HPLC method of eltrombopag olamine: Degradation pathway proposal, structure elucidation, and in silico toxicity prediction. J. Pharm. Biomed. Anal., 2021, 203, 114231.
[http://dx.doi.org/10.1016/j.jpba.2021.114231 ] [PMID: 34225039]
[21]
Patel, A.I.; Gosai, S.; Jadav, K.; Vyas, A.J.; Patel, A.B.; Patel, N.K. Stability indicating analytical method development and validation of eltrombopag olamine in tablet dosage form by RP-UPLC. J Turkish Chem Soc Sect A: Chem, 2020, 7(3), 845-850.
[http://dx.doi.org/10.18596/jotcsa.724484]
[22]
Sreelatha, G.; Rg, S.C.; Harshana, T.; Spandana, Y.D.; Reddy, Y.A. Development and validation of visible spectrophotometric method for estimation of eltrombopag olamine in bulk and tablet dosage form. Int. J. Adv. Sci. Res., 2023, 14(8), 61-65.
[http://dx.doi.org/10.55218/JASR.202314808]
[23]
Araujo, P. Key aspects of analytical method validation and linearity evaluation. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2009, 877(23), 2224-2234.
[http://dx.doi.org/10.1016/j.jchromb.2008.09.030 ] [PMID: 18929516]
[25]
Guidance document validation of analytical methods indian pharmacopoeia commission. 2021.
[26]
Siddiqui, M.R.; AlOthman, Z.A.; Rahman, N. Analytical techniques in pharmaceutical analysis: A review. Arab. J. Chem., 2017, 10, S1409-S1421.
[http://dx.doi.org/10.1016/j.arabjc.2013.04.016]

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