REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF BEMPEDOIC ACID AND EZETIMIBE IN PURE AND PHARMACEUTICAL DOSAGE FORM
Jagadeswaran C.*, Dr. Kamalakannan Dhanabalan, Dr. Manivannan R, Gokul S., Jaisri S., Thilak K., Saravanan G.
ABSTRACT
Bempedoic acid, a novel adenosine triphosphate citrate lyase (ACL) inhibitor, and ezetimibe, a cholesterol absorption inhibitor, are both utilized for managing hyperlipidemia. Bempedoic acid is specifically indicated for reducing LDL cholesterol in patients who are resistant to statins, while ezetimibe is employed either as a monotherapy or in conjunction with other cholesterol-lowering agents to control hyperlipidemia. On February 21, 2020, bempedoic acid received FDA approval. Shortly after, on February 26, 2020, NEXLIZET—a combination of bempedoic acid and ezetimibe—was also approved. This combination is prescribed to treat hypercholesterolemia and elevated triglycerides, alongside dietary modifications. A comprehensive literature review has been conducted, examining various methods for determining these drugs as both single agents and in combination forms within bulk drugs, pharmaceutical formulations, and biological fluids. The review highlights several analytical techniques, including spectrophotometry, chromatographic methods such as HPLC, RP-HPLC, and HPTLC, as well as liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Keywords: Bempedoic acid, Ezetimibe, Hyperlipidemia, HPLC, UV.
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