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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Research Article

An Easy and Rapid Spectrophotometric Method for Determination of Chloroquine Diphosphate in Tablets

Author(s): Mateus Araújo Castro e Souza*, Naialy Fernandes Araújo Reis, Larissa de Souza Batista, Isabela da Costa César, Christian Fernandes and Gerson Antônio Pianetti

Volume 16, Issue 1, 2020

Page: [5 - 11] Pages: 7

DOI: 10.2174/1573412914666180730123426

Price: $65

Abstract

Introduction: Malaria, an infectious disease caused by protozoa of the genus Plasmodium, is highly prevalent in the Brazilian Amazon. Chloroquine is the first-choice drug for the treatment of malaria caused by P. vivax and P. malariae. The humid and hot climate characteristic of the Brazilian endemic region favors drug degradation and modification of its biopharmaceutical properties, which may result in subtherapeutic dosage, formation of degradation products that can be toxic to humans and appearance of parasitic resistance. Thus, it is necessary to monitor the quality of chloroquine tablets.

Materials and Methods: An analytical method was developed and validated to determine chloroquine content in tablets by ultraviolet spectrophotometry. The diluent consisted of 0.06 M monosodium phosphate buffer pH 6.8 and detection was performed at 343 nm.

Results and Conclusion: The method proved to be linear in the range of 7.2 to 19.2 µg.mL-1, precise, accurate, selective, robust, and statistically equivalent to a liquid chromatographic method by the United States Pharmacopeia. The developed method was applied to determine chloroquine content in six batches of the drug. The evaluated batches were considered adequate for identification, assay, dissolution, disintegration and uniformity of dosage units, and were found to be inadequate in terms of friability.

Keywords: Malaria, chloroquine diphosphate, tablets, ultraviolet spectrophotometry, analytical method development, quality control.

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[1]
WHO. World Malaria Report 2015; Switzerland, 2015.
[2]
BRASIL. Ministério da Saúde. Guia Prático de Tratamento da Malária no Brasil; Brasília, 2010.
[3]
Moffat, A.C.; Osselton, M.D.; Widdop, B., Eds.; Clarke’s Analysis of Drugs and Poisons, 4th ed; Pharmaceutical Press: London, 2011.
[4]
Brunton, L.L.; Lazo, J.S.; Parker, K.L., Eds.; As bases farmacológicas da terapêutica; 11th ed; McGraw Hill: Rio de Janeiro, 2006.
[5]
WWF. Bioma: Por dentro da floresta amazônica. http://www.wwf.org.br/natureza_brasileira/areas_prioritarias/amazonia1/bioma_amazonia (Accessed on: Apr 19, 2017).
[6]
Banker, G.S.; Rhodes, C.T. Modern Pharmaceutics, 4th ed; CRC Press: Boca Raton, 2002.
[7]
Yeung, S.; Lawford, H.L.S.; Tabernero, P.; Nguon, C.; Wyk, A.; Malik, N.; Desouza, M.; Rada, O.; Boravann, M.; Dwivedi, P.; Hostetler, D.M.; Swamidoss, I.; Green, M.D.; Fernandez, F.M.; Kaur, H. Quality of antimalarials at the epicenter of antimalarial drug resistance: results from an overt and mystery client survey in Cambodia. Am. J. Trop. Med. Hyg., 2015, 92(6), 39-50.
[8]
Farmacopeia Brasileira, 5th ed; Agência Nacional de Vigilância Sanitária: Brasília, 2010.
[9]
The International Pharmacopoeia, 6th ed; World Health Organization: Geneva, 2016.
[10]
British Pharmacopoeia 2014; Her majesty´s Stationary Office: London, 2013.
[11]
USP - The United States Pharmacopeia, 38th ed; Rockville: Pharmacopeia Convention, 2015.
[12]
Coelho, A.S.; Chagas, C.E.P.; Padua, R.M.; Pianetti, G.A.; Fernandes, C. A comprehensive stability-indicating HPLC method for determination of chloroquine in active pharmaceutical ingredient and tablets: Identification of oxidation impurities. J. Pharm. Biomed. Anal., 2017, 145, 248-254.
[13]
Miranda, T.A.; Silva, P.H.R.; Pianetti, G.A.; Cesar, I.C. Simultaneous quantitation of chloroquine and primaquine by UPLC-DAD and comparison with a HPLC-DAD method. Malar. J., 2015, 14, 29.
[14]
Samanidou, V.F.; Evaggelopoulou, E.N.; Papadoyannis, I.N. Simultaneous determination of quinine and chloroquine anti-malarial agents in pharmaceuticals and biological fluids by HPLC and fluorescence detection. J. Pharm. Biomed. Anal., 2005, 38, 21-28.
[15]
César, I.C.; Nogueira, F.H.A.; Pianetti, G.A. Comparison of HPLC, UV spectrophotometry and potentiometric titration methods for the determination of lumefantrine in pharmaceutical products. J. Pharm. Biomed. Anal., 2008, 48, 223-226.
[16]
Rowe, R.C.; Sheskey, P.J.; Quinn, M., Eds.; Handbook of Pharmaceutical Excipients, 6th ed; Pharmaceutical Press and American Pharmacists Association: London, 2009.
[17]
BRASIL. ANVISA - Agência Nacional de Vigilância Sanitária. Resolução RE n. 899, de 29 de Maio de 2003. Guia para validação de métodos analíticos e bioanalíticos., 2003.
[18]
ICH. Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceutical for Human Use, Geneva2005.
[19]
Souza, S.V.C.; Junqueira, R.G. A procedure to assess linearity by ordinary least squares method. Anal. Chim. Acta, 2005, 552, 25-35.
[20]
Green, J.M. A practical guide to analytical method validation. Anal. Chem., 1996, 68, 305A-309A.
[21]
Youden, W.J.; Steiner, E. Statistical Manual of the Association of Official Analytical Chemists, 48th ed; Arlington, 1975.
[22]
César, I.C.; Pianetti, G.A. Robustness evaluation of the chromatographic method for the quantitation of lumefantrine using Youden’s test. Braz. J. Pharm. Sci., 2009, 45, 235-240.
[23]
United States. Department of Health and Human Services. Food and drug Administration. Center for Drug Evaluation and Research (CDER). Reviewer Guidance: Validation of Chromatographic Methods; FDA: Rockville, 1994.
[24]
Aulton, M.E. Delineamento de formas farmacêuticas, 2nd ed; Artmed: Porto Alegre, 2005.

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