Novel Column Chemistry—High Impact, Low Cost Technology

The three areas of development in HPLC that are most significant to the pharmaceutical industry are the implementation of fast LC (UHPLC), the increased applicability of LC mass spectrometry (LC/MS), and the development of novel column chemistries. These three factors have invigorated the HPLC market because they are major contributors to the development of pharmaceuticals and are substantial considerations in laboratory design. Without question, the higher sample throughput of UHPLC and the data quality of LC/MS are very beneficial to an industry striving to improve data quality, while reducing drug development time. However, making LC/MS and UHPLC accessible to the laboratory requires a technology change, a paradigm shift, and a large expenditure in capital equipment. Novel column chemistries, by comparison, are a simple change in an already budgeted consumable that can lead to optimized and more reliable methods—giving a fast return on a minimal investment.

Column Choice: A Critical Factor for Successful UHPLC Integration

Ultra High Pressure Liquid Chromatography (UHPLC) is an increasingly popular platform for analytical method development in the pharmaceutical laboratory. Higher productivity can be realized with this technique, ultimately offsetting some of the rising costs of drug development. However, the challenge we now face is seamlessly integrating methods developed using UHPLC into pharmaceutical labs, which are still dominated by conventional HPLC systems. Column choice is a critical factor in successfully transferring methods between UHPLC and HPLC—poor choices ultimately cause failure or costly delays in development and transfer. Here, we discuss what attributes are needed from the analytical column, and how these qualities contribute to the successful integration of UHPLC technology into pharmaceutical labs.

High Pressure Liquid Chromatography (HPLC) is the cornerstone analytical technique of the pharmaceutical laboratory; it is employed in every segment of drug development, from discovery through final product testing. However, HPLC is fundamentally restricted by the pressure limitations of the instrumentation, which effectively limit the particle sizes used in column packings to 3 micron or larger size particles. Recently, the advent of Ultra High Pressure Liquid Chromatography (UHPLC) spurred the next leap in liquid chromatographic techniques, offering higher pressure limits, faster throughput, and the promise of ultimately lowering operating costs. Higher productivity can be achieved by developing methods using <2 micron particle size columns in conjunction with UHPLC instrumentation, however, the UHPLC method generally must be scaled to conventional HPLC for routine analysis.

The Next Hurdle—Integration