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Abstract
Ethylene Glycol (EG) and Diethylene Glycol (DEG) are toxic glycol contaminants that pose a significant safety risk when present in pharmaceutical excipients such as sorbitol solution. Several global poisoning incidents linked to EG and DEG contamination have emphasized the need for rigorous monitoring and precise analytical determination of these impurities. Sorbitol solution, widely used as a sweetener and humectant in oral liquid formulations, must therefore comply with stringent regulatory limits established by pharmacopoeias and international health authorities. The present study focuses on the development and evaluation of a sensitive and robust Gas Chromatography (GC) method with Flame Ionization Detection (FID) for the accurate quantification of EG and DEG in sorbitol solution. The method employs 2,2,2-trichloroethanol as an internal standard and optimized chromatographic conditions to achieve reliable separation and quantification. System suitability parameters such as %RSD, retention time consistency, and peak tailing were evaluated to ensure method reliability. The method demonstrated excellent sensitivity, with low LOD and LOQ values for both analytes, ensuring the ability to detect contamination even at trace levels. Sample preparation procedures were standardized to minimize matrix interference and enhance method precision. Overall, the validated GC-FID method proved effective for routine quality control testing, supporting compliance with pharmacopeial specifications and safeguarding the quality of sorbitol-containing pharmaceutical products. This analytical approach strengthens the quality assurance framework and contributes to preventing toxic glycol contamination in pharmaceutical excipients.