The Quality Control of Ethyl Glucuronide Standards

Alcohol is a commonly abused drug and can lead to occupational, pregnancy and driving hazards. It is important to monitor alcohol consumption to attempt to avoid these potentially hazardous situations. Ethyl glucuronide ( EtG) is a direct metabolite of ethanol and its determination in biological samples, especially urine, has gained popularity as a biomarker of alcohol consumption. Monitoring ethanol metabolites helps to distinguish between alcohol consumption and post- mortem production of ethanol. Recently, there has been a growing need for commercially available analytical standards for the target compound, EtG. The legal ramifications of challenge testing for alcohol abuse require stringent quality control of these reagents. High performance liquid chromatography followed by pulsed electrochemical detection ( HPLC- PED), offers unique advantages for assessing the purity of ethyl glucuronide standards. This thesis discusses in detail the development and validation of an HPLC- PED method. The method was validated for the purity assay of EtG standards in DI water. Additionally, purity assays of three commercially- available EtG standards are shown to highlight the successful application of this method. Results obtained from the HPLC- PED method were compared to those obtained using refractive index detection, a universal method of detection. HPLC- PED was found to be a valid method for sensitive and selective determination of EtG standards. Overall, this method meets the needs of quality control in the production of EtG to ensure the consumer obtains the highest possible quality standards achievable