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Updated: Oct 24, 2025

Untargeted Metabolomics from Biological Sources Using Ultraperformance Liquid Chromatography-High Resolution Mass Spectrometry UPLC-HRMS
Published on: May 20, 2013
Stability-indicating method development for quantification of bromopride, its impurities, and degradation products by
Juliana Caldeira Abreu1, Amanda Guiraldelli Mahr1, Claudimir Lucio do Lago1
1Department of Fundamental Chemistry, Institute of Chemistry, University of São Paulo, Av. Prof. Lineu Prestes 748, SP, 05508-900, São Paulo, Brazil.
Abstract:
A comprehensive forced degradation study for bromopride was carried out in accordance with International 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 Operable 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.
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