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

被引：12
作者：
Abreu, Juliana Caldeira [1 ]
Mahr, Amanda Guiraldelli [1 ,2 ]
do Lago, Claudimir Lucio [1 ]
机构：
[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
来源：
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2021年 / 205卷
基金：
巴西圣保罗研究基金会;
关键词：
Stress testing; Stability-indicating method; Analytical quality by design; Monte Carlo simulation; Chemometrics; MASS-SPECTROMETRY; HUMAN-PLASMA; LC METHOD;
D O I：
10.1016/j.jpba.2021.114306
中图分类号：
O65 [分析化学];
学科分类号：
070302 ; 081704 ;
摘要：
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.
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页数：9
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