应用分析质量源于设计原理的超高效液相色谱法对溴必利及其杂质和降解产物进行定量的稳定性指示方法开发。
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.
机构信息
Department of Fundamental Chemistry, Institute of Chemistry, University of São Paulo, Av. Prof. Lineu Prestes 748, SP, 05508-900, São Paulo, Brazil.
Department of Fundamental Chemistry, Institute of Chemistry, University of São Paulo, Av. Prof. Lineu Prestes 748, SP, 05508-900, São Paulo, Brazil.
出版信息
J Pharm Biomed Anal. 2021 Oct 25;205:114306. doi: 10.1016/j.jpba.2021.114306. Epub 2021 Aug 3.
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.
按照国际人用药品注册技术协调会（ICH）的建议，对溴必利进行了全面的强制降解研究，随后对主要降解产物进行了鉴定和探索。通过设计分析质量（AQbD）的概念，开发了一种溴必利和五种有机杂质的定量分析方法，采用超高效液相色谱法与紫外检测（UHPLC-UV）。进行了两次筛选和一次优化设计，包括蒙特卡罗模拟来评估方法可操作设计区域（MODR）。AQbD 方法在很短的时间内（不到两周）提供了对方法的高度理解，验证后的 MODR 提供了有关稳健分析条件的信息，有助于确定合适的控制策略。
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