强制降级
色谱法
杂质
仿形(计算机编程)
分析技术
生化工程
降级(电信)
毛细管电泳
化学
活性成分
高效液相色谱法
计算机科学
反相色谱法
生物信息学
有机化学
工程类
操作系统
生物
电信
作者
Maryam Jahani,Bibi Sedigheh Fazly Bazzaz,Maryam Akaberi,Omid Rajabi,Farzin Hadizadeh
标识
DOI:10.1080/10408347.2021.2008226
摘要
Forced degradation studies have been used to simplify analytical methodology development and achieve a deeper knowledge about the inherent stability of active pharmaceutical ingredients (API) and drug products. This provides insight into degradation species and pathways. Identification of impurities in pharmaceutical products is closely related to the selection of the most appropriate analytical methods like HPLC-UV, LC-MS/MS, LC-NMR, GC-MS, and capillary electrophoresis. Herein, recent trends in analytical perspectives during 2018–April 14, 2021, are discussed based on forced and impurity degradation profiling of pharmaceuticals. Literature review showed that several methods have been used for experimental design and analysis conditions such as matrix type, column type, mobile phase, elution modes, detection wavelengths, and therapeutic category. Thus, since these factors influence the separation and identification of the impurities and degradation products, we attempted to perform a statistical analysis for the developed methods according to the abovementioned factors.
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