UV Spectrophotometric method for quantitative determination of Bilastine using experimental design for robustness

Andressa Tassinari da Silva; Gabriela Rossi Brabo; Isadora Dias Marques; Lisiane Bajerski; Marcelo Donadel Malesuik; Clésio Soldateli Paim

doi:10.22456/2527-2616.79221

Authors

Andressa Tassinari da Silva Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade do Curso de Farmácia na Universidade Federal do Pampa
Gabriela Rossi Brabo Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade do Curso de Farmácia na Universidade Federal do Pampa
Isadora Dias Marques Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade do Curso de Farmácia na Universidade Federal do Pampa; Programa de Pós-Graduação em Ciências Farmacêuticas da Universidade Federal do Pampa
Lisiane Bajerski Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade do Curso de Farmácia na Universidade Federal do Pampa
Marcelo Donadel Malesuik Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade do Curso de Farmácia na Universidade Federal do Pampa; Programa de Pós-Graduação em Ciências Farmacêuticas da Universidade Federal do Pampa
Clésio Soldateli Paim Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade do Curso de Farmácia na Universidade Federal do Pampa; Programa de Pós-Graduação em Ciências Farmacêuticas da Universidade Federal do Pampa

DOI:

https://doi.org/10.22456/2527-2616.79221

Keywords:

bilastine, experimental design, UV spectrophotometric method

Abstract

Bilastine is a novel nonsedative H1-receptor antagonist, which may be used for the symptomatic treatment of chronic idiopathic urticaria (CU). This study describes the validation of an UV spectrophotometric method for quantitative determination of bilastine in tablets using 0.1 mol L^-1 HCl as solvent. The method was specific, linear, precise, exact and robust at 210 nm, confirming that the method is fast and useful to the routine quality control of bilastine in tablets. The validate method was compared to liquid chromatography (HPLC), which was previously developed and validated to the same drug, and no significative difference between the methods using Student´s t test was found to bilastine quantitation.

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References

Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, et al. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebocontrolled study. Allergy 2010;65(4):516- 528.

Scaglionte F. Safety profile of bilastine: 2nd generation H1-antihistamines. Eur Rev Med Pharmacol Sci. 2012;16(14):1999- 2005.

Berrueta LA, Fernandez-Armentia M, Bakkali A, Gonzalo A, Lucero ML, Orjales A. Matrix solid-phase dispersion technique for the determination of a new antiallergic drug, bilastine, in rat faeces. J Chromatogr B 2001; 760:185–190.

Lasseter KC, Sologuren A, La Noce A, Dilzer SC. Evaluation of the single-dose pharmacokinetics of bilastine in subjects with various degrees of renal insufficiency. Clin Drug Investi 2013; 33:665-673.

Terzić J, Popović I, Stajić A, Tumpa A, Jancić-Stojanović B. Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interactionliquid chromatographic method. J Pharm Biomed Anal 2016; 125:385–393.

ICH. Harmonised Tripartide Guideline: Validation of Analytical Procedure: Text and Methodology Q2 (R1), 2005. http://www.ich.org/LOB/media/MEDIA4 17.pdf, acessado em Abril de 2017.

The United States Pharmacopeia, 38th ed., United States Pharmacopeial Convention: Rockville, 2015.

Heyden YV, Nijhuis A, SmeyersVerbeke, J, Vandeginste, BGM, Massart DL. Guidance for robustness/ruggedness tests in method validation. J Pharm Biomed Anal 2001;24:723-753.

Watson, GD. Pharmaceutical Analysis: A textbook for pharmacy students and pharmaceutical chemists, 2nd ed. Churchill Livingstone: London; 2005.