FORCED DEGRADATION AND STABILITY STUDY OF LENALIDOMIDE: IMPURITY PROFILING AND METHOD DEVELOPMENT USING HPLC

Lenalidomide is an immunomodulatory drug that plays a significant role in treating hematological conditions, including multiple myeloma and myelodysplastic syndromes. The stability of lenalidomide is crucial for maintaining its safety and effectiveness throughout its shelf life. Environmental factors such as light, heat, moisture, and changes in pH can lead to the degradation of lenalidomide, resulting in harmful impurities that may compromise its therapeutic potency. This research presents a novel approach to studying the stability of lenalidomide under various stress conditions using a High-Performance Liquid Chromatography method. The method is designed to investigate degradation pathways and impurity profiling. It incorporates a dynamic gradient system and optimizes the mobile phase composition to enhance the separation of degradation products with improved precision and reproducibility. The research also integrates green chemistry principles, minimizing the use of harmful solvents and reducing the environmental impact. Forced degradation studies were conducted under various stress conditions, such as ultraviolet light, heat, acidic, alkaline, and oxidative conditions, revealing previously unknown degradation products. The results of these studies offer essential insights into the stability of lenalidomide, providing valuable recommendations for improving formulation and storage conditions. This validated High-Performance Liquid Chromatography method proves to be a reliable, eco-friendly, and efficient tool for routine quality control and stability testing, ensuring the safety and effectiveness of lenalidomide.