Gadolinium-based contrast agents (GBCAs) are paramagnetic metal chelates used clinically to enhance the contrast of soft tissue in magnetic resonance imaging (MRI). It is known that free gadolinium is toxic and can cause damage a number of organs in the human body, if retained in the body after treatment.  Investigation of drug stability of the different GBCAs is important for better mechanistic understanding of the stability of the Gadolinium-ligand complex and the presence of free ligand, and free gadolinium. Quantitative measurements of total gadolinium concentration in drug formulations do not address the potential presence of free gadolinium. Here, we developed a speciation method to separate the different species (Gadolinium-ligand, ligand, and Gadolinium) that may exist in the drug formulation by ultra-high performance liquid chromatography (UPLC) separation and inductively coupled plasma mass spectrometry detection (ICP-MS). Quantitation of these species will help to create a comprehensive approach to monitor GBCA drug stability. Furthermore, the monitoring of drug samples that have undergone stress test (heating, cooling, light exposure, pH modifications, and completive ions Na, Ca, Fe, etc) may help provide greater scientific understanding on what causes the degradation of these drug products and provide a better assessment of demetallization kinetics and drug stability.<br/>

Method development for speciation of gadolinium based contrast agents by UPLC-ICP-MS

254th National Meeting (2017)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.