STABILITY-INDICATING METHODS IN FORCED DEGRADATION STUDIES: A CRITICAL REVIEW OF ANALYTICAL APPROACHES AND REGULATORY PERSPECTIVES
DOI:
https://doi.org/10.61114/UJPSR.10.1.2026.51-59Keywords:
Forced degradation, HPLC, GCMS, LC-MS, stability indicating methods, regulatory guidelines, analytical methods, hyphenated techniquesAbstract
ABSTRACT
Forced degradation studies are essential for the investigation of the inherent stability and degradation behavior of drug substances and drug products. This study involves the exposure of pharmaceutical compounds to a variety of accelerated chemical and environmental stress conditions in order to produce degradation products that can be used for the clarification of the degradation pathways as well as for the development of stability–indicating analytical procedures. Regulatory guidelines offer general recommendations; however, there are no specific and standardized practices, resulting in differences in how investigations are conducted. This review critically analyzes regulatory viewpoints, frequently used stress conditions, and contemporary analytical methods such as UV spectrophotometry, HPLC, GC–MS, and LC–MS for degradation studies. In this review these techniques are compared with respect to their sensitivity, specificity, cost, and applicability. Recent advances such as hyphenated techniques are also discussed. The review underlines the importance of method selection based on the analytical requirements and discusses the future trends in stability–indicating method development.
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