Evaluation Of Forced Degradation Behavior of Bempedoic Acid in Different Indian Branded Tablet Formulations

Bempedoic acid, a key medication for lowering low-density lipoprotein cholesterol (LDL-C), is particularly useful for patients who are intolerant to statins or require additional LDL-C reduction. This study aims to evaluate the forced degradation behavior of Bempedoic acid under stress conditions using UV spectroscopy. The drug's stability was assessed in three tablet formulations: BEMPESTA (Torrent Pharmaceutical LTD, Tablet A), nexRed (Dr. Reddy’s Laboratory LMD, Tablet B), and CONSIVAS-BM (Emcure Pharmaceutical LTD, Tablet C), under various stress conditions, including acidic and basic hydrolysis, oxidation, and thermal exposure. UV absorbance measurements were taken at 258 nm using methanol as the solvent. The degradation results varied across formulations and stress conditions. Tablet A exhibited degradation of 78.02% in acidic, 85.01% in basic, 85.68% in oxidative, and 79.95% in thermal conditions. Under similar conditions, Tablet B showed 65.43%, 56.36%, 55.41%, and 61.59% degradation, respectively, while Tablet C exhibited 53.47%, 43.09%, 65.23%, and 21.76% degradation. This study provides key insights into Bempedoic acid degradation pathways, crucial for optimizing formulation and ensuring safety. The method is simple, time-efficient, and cost-effective, making it suitable for assessing Bempedoic Acid stress degradation, especially in smaller industries with limited access to advanced instruments.