Development and validation of a gas chromatography method for the quantitative determination of ethylene glycol and diethylene glycol in effervescent tablets

Introduction. Excipients used in the production of solid dosage forms may contain impurities of ethylene glycol and diethylene glycol, posing a potential risk to patient safety. Due to the high toxicity of these compounds and reported poisoning cases, their presence in pharmaceutical products must be strictly controlled. Currently, standardized analytical methods have been developed for liquid dosage forms, however, their application to other pharmaceutical forms requires adaptation, considering differences in composition and sample preparation. Objective: to develop and validate a gas chromatography method for the quantitative determination of ethylene glycol and diethylene glycol in effervescent tablets. Material and methods. The object of the study was effervescent tablets containing polyethylene glycol (PEG-6000) as an excipient. The analysis was carried out using a Chromateс Crystal 5000.2 gas chromatograph with a flame ionization detector. The validation included the assessment of specificity, linearity, LOQ, precision, accuracy, analytical range, robustness, and stability. Results. The developed method ensures the selective determination of ethylene glycol and diethylene glycol in effervescent tablets. Optimized sample preparation conditions provide efficient extraction of target compounds. During validation, the method was confirmed to meet the established criteria for all evaluated parameters. The method is applicable for the quantitative determination of ethylene glycol and diethylene glycol in the concentration range from LOQ to 150% of the specification level. However, due to the limited stability of solutions, it is necessary to strictly adhere to the specified storage conditions. Conclusion. A gas chromatography method with flame ionization detection has been developed and validated for the quantitative determination of ethylene glycol and diethylene glycol in effervescent tablets. The method meets the established requirements and can be used for quality control of solid dosage forms. Keywords: