Abstract

REVIEW ON ANALYTICAL METHODS DEVELOPMENT AND VALIDATION FOR EZETIMIBE AS AN ANTI-HYPERLIPIDEMIC AGENT

Parth M. Patel*, Smit B. Patel, Tisha S. Patel, Fatema M. Vohra, Priyank G. Patel

Abstract

Ezetimibe is a cholesterol-lowering medication that works by selectively inhibiting the absorption of cholesterol from the small intestine. It is used alone or in combination with other drugs like statins to treat high cholesterol levels and prevent cardiovascular disease. By blocking cholesterol absorption, ezetimibe reduces total, LDL, and non-HDL cholesterol, and can also affect other lipids like triglycerides and HDLcholesterol. The present review focuses on the development and validation of analytical methods for the estimation of ezetimibe in bulk drug and pharmaceutical dosage forms. Various analytical techniques reported in the literature, including UV-Visible spectrophotometry, High Performance Liquid Chromatography (HPLC), and High Performance Thin Layer Chromatography (HPTLC), are critically discussed. Emphasis is given to method development strategies, selection of solvents, detection wavelengths, chromatographic conditions, and validation parameters as per International Council for Harmonisation (ICH) guidelines. Overall, this review confirms that properly developed and validated analytical methods are essential for ensuring the quality, safety, and efficacy of ezetimibe as an antihyperlipidemic agent in pharmaceutical industries.

Keywords: Ezetimibe, Hyperlipidemia, Cholesterol absorption inhibitor, Analytical method development, Method validation, UV–Visible spectrophotometry, HPLC, HPTLC, ICH guidelines.