Authors: Dr. Anjali Sharma, Dr. Karan Singh
Abstract: Stability of pharmaceutical formulations is a critical factor influencing drug efficacy, safety, and shelf-life. Stability-indicating methods (SIMs) are analytical techniques capable of detecting and quantifying active pharmaceutical ingredients (APIs) and their degradation products under various stress conditions. This paper reviews the principles, selection criteria, and validation requirements of SIMs for drug development and quality control. Emphasis is placed on chromatographic, spectroscopic, and hyphenated techniques, along with forced degradation studies for stress testing. Case studies highlight the application of high-performance liquid chromatography (HPLC), UV-Vis spectrophotometry, and LC-MS in stability assessment. The role of regulatory guidelines, method validation, and practical considerations in formulation development are discussed. Future trends involving automated and miniaturized SIMs for rapid analysis are explored.
Keywords: Stability-indicating methods, Forced degradation, HPLC, LC-MS, Pharmaceutical formulations, Method validation, Degradation products, Quality control.
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