Stability-indicating method development for quantification of bromopride, its impurities, and degradation products by ultra-high performance liquid chromatography applying Analytical Quality by Design principles

Autor(es)

Abreu, Juliana Caldeira ^[1] ; Mahr, Amanda Guiraldelli ^{[1, 2]} ; do Lago, Claudimir Lucio ^[1]

Afiliação do(s) autor(es)

^[1] Univ Sao Paulo, Dept Fundamental Chem, Inst Chem, Av Prof Lineu Prestes 748, BR-05508900 Sao Paulo, SP - Brazil

^[2] Univ Campinas Unicamp, Inst Chem, Dept Analyt Chem, BR-13083970 Campinas, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Journal of Pharmaceutical and Biomedical Analysis; v. 205, OCT 25 2021.
• Citações Web of Science: 0

Resumo

A comprehensive forced degradation study for bromopride was carried out in accordance with Inter-national Conference on Harmonization (ICH) recommendations followed by the identification and prospecting of the major degradation products. The analytical quality by design (AQbD) concepts were used to develop a stability-indicating method for bromopride and five organic impurities quantitation by ultra-high performance liquid chromatography with UV detection (UHPLC-UV). Two screenings and one optimization design were performed, including a Monte Carlo simulation to assess the Method Opera-ble Design Region (MODR). The AQbD approach provided a high degree of method understanding in a very short period of time, less than two weeks, and the validated MODR provided information on robust analytical conditions contributing to the assignment of suitable control strategies. (c) 2021 Elsevier B.V. All rights reserved. (AU)

• Processo FAPESP: 17/13137-5 - Formação e propriedades de hemiésteres do ácido carbônico em meio aquoso
• Beneficiário: Claudimir Lucio Do Lago
• Modalidade de apoio: Auxílio à Pesquisa - Temático
• Processo FAPESP: 12/06642-1 - Formação e propriedades de adutos de hidróxi-compostos orgânicos com carbonato em meio aquoso e condições biológicas
• Beneficiário: Claudimir Lucio Do Lago
• Modalidade de apoio: Auxílio à Pesquisa - Regular