International Journal of Pharmacognosy and Chemistry https://www.saapjournals.org/index.php/ijpc <p>International Journal of Pharmacognosy and Chemistry</p> en-US <p>Copyright © Author(s) retain the copyright of this article.</p> editor.ijpc@saap.org.in (Editor in Chief) info@saap.org.in (G.V. Nagaraju) Thu, 15 Jan 2026 00:00:00 +0530 OJS 3.1.2.4 http://blogs.law.harvard.edu/tech/rss 60 Forced Degradation Studies in Analytical Method Development for Pharmaceuticals: A Comprehensive Review https://www.saapjournals.org/index.php/ijpc/article/view/841 <p>Forced degradation studies, also known as stress testing, are essential tools in pharmaceutical analysis for understanding the intrinsic stability of drug substances and products. These studies involve subjecting drugs to extreme conditions to generate degradation products, thereby enabling the development of stability-indicating analytical methods. Such methods are critical for accurately distinguishing the active pharmaceutical ingredient from its degradation impurities, ensuring drug safety, efficacy, and quality. Typically, forced degradation is performed under a variety of stress conditions, including acidic and alkaline hydrolysis, oxidative degradation, thermal stress, and photolytic exposure. Each condition provides insight into specific degradation pathways and mechanisms. Advanced analytical techniques such as high-performance liquid chromatography (HPLC), liquid chromatography–mass spectrometry (LC–MS), gas chromatography–mass spectrometry (GC–MS), and photodiode array (PDA) detection are widely employed for the separation, identification, and characterisation of degradation products. These studies play a pivotal role in method development, validation, impurity profiling, and regulatory submissions. Overall, forced degradation studies are indispensable in ensuring the development of robust, reliable, and stability-indicating analytical methods in the pharmaceutical industry.</p> Kiran Kumar Byram, Sagar Patel, Chirag Patel, Shravan Kumar Muthyam Copyright (c) 2026 https://creativecommons.org/licenses/by-nc/4.0 https://www.saapjournals.org/index.php/ijpc/article/view/841 Sat, 28 Feb 2026 00:00:00 +0530