Research Project
9464782
Abstract The analysis of molecules (analytes) by liquid chromatography (LC) is performed in all areas of healthcare from drug discovery and development to disease diagnosis. Here, we propose a near-universal LC detector utilizing a flame ionization detector (FID) that responds with high sensitivity to all organic compounds. This technology has the potential to speed up pharmaceutical development and allow for more accurate quantification of the components in pharmaceuticals. Ultimately, this will improve all aspects of healthcare that rely on LC. This research and potential commercialization is supported by our concurrent development and product launch success with corporate partners in the gas chromatography (GC) market. The purpose of LC is to determine how much of each molecule is in a sample. Because of the complexity associated with the number of molecules that exist in a sample, LC can be the most time-consuming analytical technique in pharmaceutical development. Nevertheless, it is still the best technique for molecular quantification of pharmaceuticals. LC relies on two equally-important primary steps: separation followed by detection. Separation technologies have evolved over recent years to increase chromatographic resolution and speed up analysis. Similarly, detectors such as mass spectrometers (MS) have become more sensitive and selective, allowing users to quickly identify components in a complex matrix. The UV detector is used by >90% of LC users for quantification because it is low-cost and reliable. However, even with modern improvements, the UV detector cannot overcome its fundamental limitation, which is its non-uniform response to organic molecules, resulting in missed detection and sometimes poor quantification. Our proposed product is a higher-performing, yet low-cost, alternative to the UV detector. The specific aims of this proposal include the proof-of-concept testing necessary for utilization of an FID with an LC. With over 60 years of practice in GC, the FID has proven to be a sensitive and reliable detector with a linear range over seven orders-of-magnitude. Implementation of the FID in LC, however, requires the removal of the mobile phase, which would otherwise drown out the signal of analytes. Previous attempts of solvent removal have been unsuccessful due to the challenges of continuous solvent removal and the requisite transfer of nonvolatile analytes to the detector. Advances in catalytic microreactor technology, pioneered by Activated Research Company, now provide the technology necessary for the implementation of FID in LC. Successful completion of the Phase I aims will lead to a Phase II commercialization strategy to bring this product to healthcare markets. This proposal has obtained the enthusiastic support of leading LC and pharmaceutical companies offering a high probability of commercialization after meeting the project milestones.
