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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

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

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Author(s):
Abreu, Juliana Caldeira [1] ; Mahr, Amanda Guiraldelli [1, 2] ; do Lago, Claudimir Lucio [1]
Total Authors: 3
Affiliation:
[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
Total Affiliations: 2
Document type: Journal article
Source: Journal of Pharmaceutical and Biomedical Analysis; v. 205, OCT 25 2021.
Web of Science Citations: 0
Abstract

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)

FAPESP's process: 17/13137-5 - Formation and properties of hemiesters of carbonic acid in aqueous medium
Grantee:Claudimir Lucio Do Lago
Support Opportunities: Research Projects - Thematic Grants
FAPESP's process: 12/06642-1 - Formation and properties of adducts of organic hydroxy-compounds with carbonate in aqueous medium and biological conditions
Grantee:Claudimir Lucio Do Lago
Support Opportunities: Regular Research Grants