Analytical Method Development and Validation for the Determination of Ethylene Glycol and Diethylene Glycol in Herbal Cough Syrup by Gas Chromatography

Abstract

Ethylene Glycol (EG) and Diethylene Glycol (DEG) are potential contaminants in liquid oral formulations, posing severe toxicological risks. Regulatory agencies mandate stringent controls on their permissible limits. This study outlines the analytical method verification of a gas chromatography (GC) procedure for the quantitative determination of EG and DEG in a polyherbal cough syrup. The method employs a DB-624 capillary column and flame ionization detection (FID), using ethanol as the diluent. System suitability, precision, resolution, and tailing factor criteria were established and verified. The method was confirmed to be accurate, precise, and suitable for routine use in quality control.