Recent Progresses in Analytical Perspectives of Degradation Studies and Impurity Profiling in Pharmaceutical Developments: An Updated Review

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...

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Bibliographic Details
Published in:Critical reviews in analytical chemistry 2023, Vol.53 (5), p.1094-1115
Main Authors: Jahani, Maryam, Fazly Bazzaz, Bibi Sedigheh, Akaberi, Maryam, Rajabi, Omid, Hadizadeh, Farzin
Format: Article
Language:English
Subjects:
Active pharmaceutical ingredients
Analytical methods
Capillary electrophoresis
Chromatography, High Pressure Liquid - methods
Chromatography, Liquid
Degradation
Degradation products
Design of experiments
Drug Contamination
Electrophoresis
Experimental design
forced degradation
HPLC-UV
Impurities
impurity profiling
LC-MS/MS
Liquid chromatography
Literature reviews
Mathematical analysis
NMR
Nuclear magnetic resonance
Pharmaceutical Preparations
Pharmaceuticals
Statistical analysis
Tandem Mass Spectrometry
Wavelengths
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Summary: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.
ISSN:1040-8347
1547-6510
DOI:10.1080/10408347.2021.2008226