Bilastine: stability-indicating a method using environmentally friendly by reversed-phase high-performance liquid chromatography (RP-HPLC)

Paulo Roberto Rodrigues Martini; Douglas dos Santos Porto; Paola Ribeiro Motta; Lisiane Bajerski; Marcelo Donadel Malesuik; Clésio Soldateli Paim

doi:10.22456/2527-2616.120940

Authors

Paulo Roberto Rodrigues Martini Laboratório de Controle de Qualidade e Desenvolvimento de Medicamentos - Universidade Federal do Pampa
Douglas dos Santos Porto Laboratório de Controle de Qualidade e Desenvolvimento de Medicamentos - Universidade Federal do Pampa
Paola Ribeiro Motta Laboratório de Controle de Qualidade e Desenvolvimento de Medicamentos; Programa de Pós-Graduação em Ciências Farmacêuticas - Universidade Federal do Pampa
Lisiane Bajerski Laboratório de Controle de Qualidade e Desenvolvimento de Medicamentos - Universidade Federal do Pampa
Marcelo Donadel Malesuik Laboratório de Controle de Qualidade e Desenvolvimento de Medicamentos; Programa de Pós-Graduação em Ciências Farmacêuticas - Universidade Federal do Pampa
Clésio Soldateli Paim Laboratório de Controle de Qualidade e Desenvolvimento de Medicamentos - Universidade Federal do Pampa

DOI:

https://doi.org/10.22456/2527-2616.120940

Keywords:

bilastine, ecofriendly method, stability-indicating

Abstract

This study describes the development and validation of a new environmentally friendly analytical method for the determination of bilastine in coated tablets and the evaluation of its capacity to be stability-indicating as well. The ecofriendly analytical method was validated by specificity, linearity, accuracy, precision and robustness by reversed-phase high-performance liquid chromatography (RP-HPLC) according to International Conference on Harmonization guidelines (ICH) and Association of Official Analytical Chemists (AOAC). Isocratic LC separation was achieved on a RP18 column using a mobile phase of sodium dihydrogen phosphate aqueous buffer solution adjusted to pH (6.0 ± 0.1) with o-phosphoric acid (85% v/v) and triethylamine (0,3% v/v) and ethanol (EtOH) in the following proportions (60:40 v/v), at a flow rate of 1.0 mL·min^-1 at temperature-controlled at 30 °C. The analytical method showed selectivity, good recovery and precision (intra- and inter-day), robustness, and linear over a range from 5.0 to 50 μg·mL^-1.

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