A Comprehensive Review on Analytical Method Development and Validation for Combination of Bempedoic Acid and Ezetimibe in Pharmaceutical Dosage Form

This review article provides a comprehensive overview of two antihyperlipidemic medications, bempedoic acid and ezetimibe, focusing on their mechanisms of action, pharmacokinetics, adverse effects, and physiochemical properties. Hyperlipidemia, characterized by high levels of lipids like total cholesterol, LDL cholesterol, and triglycerides, is a major risk factor for cardiovascular diseases. Bempedoic acid, a first-in-class drug, works by inhibiting the enzyme adenosine triphosphate-citrate lyase (ACL) in the liver, which reduces cholesterol synthesis and increases LDL clearance. Ezetimibe, on the other hand, lowers cholesterol by inhibiting its absorption at the brush border of the small intestine. Both drugs are used to manage high cholesterol and have been shown to reduce LDL and total cholesterol levels. The article also reviews various analytical methods used for the quantitative analysis of these drugs, both individually and in combination. These methods include UV-Visible spectroscopy, RP-HPLC, HPTLC, and UPLC, highlighting different solvent systems, stationary phases, and detection wavelengths employed in various studies. The documented analytical methods provide a foundation for quality control and research of these important lipid-lowering agents.