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

Authors

  • Paulo Roberto Rodrigues Martini Federal University of Pampa http://orcid.org/0000-0003-2829-7320
  • Douglas dos Santos Porto
  • Paola Ribeiro Motta
  • Lisiane Bajerski
  • Marcelo Donadel Malesuik
  • Clésio Soldateli Paim

DOI:

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

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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Published

2022-07-28

How to Cite

Martini, P. R. R., dos Santos Porto, D., Ribeiro Motta, P., Bajerski, L., Donadel Malesuik, M., & Soldateli Paim, C. (2022). Bilastine: stability-indicating a method using environmentally friendly by reversed-phase high-performance liquid chromatography (RP-HPLC). Drug Analytical Research, 6(1), 13–20. https://doi.org/10.22456/2527-2616.120940

Issue

Section

ORIGINAL ARTICLES