Advanced HPLC/UHPLC 2: Pharmaceutical Applications and UHPLC Concepts, Practices and Potential Issues Online Course
An overview of separation science in pharmaceutical discovery and development, high-throughput purification, preclinical research and chemistry, manufacturing and control (CMC), formulation, the role of the analytical chemist, techniques for physicochemical characterization
- Maintenance and Troubleshooting
- Method Development and Validation
- Novel approaches and recent advances in HPLC
This course will introduce you to best practices of high-performance liquid chromatography (HPLC) and ultra-high-pressure LC (UHPLC) as well as tricks-of-the-trade for successful HPLC operation. The attendees will learn step-by-step guide to operating HPLC modules, maintenance procedures, troubleshooting strategies, traditional and accelerated method development processes as well as recent advances of this pervasive analytical technique including UHPLC. This is the second part of a two-course series to Modern HPLC introduction.
Recommended Textbook: M. W. Dong, Modern HPLC for Practicing Scientists, Wiley-Interscience, New Jersey, 2006. This book is used as a course reference and supplements the course presentation handouts.
Who Should Attend
Analysts, scientists, researchers and managers who want to get an updated introduction of modern HPLC practices, troubleshooting, method development and recent advances of UHPLC. You should have a good understanding of general chemistry. Some prior hands-on HPLC/UHPLC experience would be helpful. This course is conducted at an intermediate level.
The attendee will get a critical overview of the applications of separation science from drug discovery, analytical develop to quality control including the best practice in small molecule drug development and the analysis of recombinant biologics. The attendee will also learn the benefits, best practices and potential issue of UHPLC in pharmaceutical analysis.
M. W. Dong, Modern HPLC for Practicing Scientists, Wiley-Interscience, New Jersey, 2006 (ISBN-10: 047172789X).
Pharmaceutical Analysis Applications and Best Practices
- An overview of separation science in pharmaceutical discovery and development, high-throughput purification, preclinical research and chemistry, manufacturing and control (CMC), formulation, the role of the analytical chemist, techniques for physicochemical characterization
- Practice and case studies of HPLC small molecule drugs analysis:
- potency assay, stability-indicating methods, stability study, dissolution testing, chiral separations, certificates of analysis of drug substance and drug product, references
- Analysis of recombinant biological products, overview of monoclonal antibodies (mAb) and their bioprocessing, structure characteristics, differences of small molecule drugs vs. mAb, specifications, case studies of QC of mAb using SEC, IEC, RPC, peptide mapping, and HIC
UHPLC: Concept and benefits
- Overview and perspectives, a modern HPLC platform, concepts (need for high pressure, void volume, peak volume, dwell volume, instrumental bandwidth), a flow cell design
- Benefits and case studies: very fast separations with good resolution, very high resolution analysis of complex samples, and the ability to facilitating rapid method development, and references
UHPLC: Potential Issues, practice and implementation
- Potential issues and how to mitigate (viscous heating, operating nuances, compatibility to existing methods, injection precision, detector sensitivity vs. dwell volumes)
- Method translation and transfer issues/case study, how to transition from HPLC to UHPLC, end-fittings, performance tradeoffs, references
About the Instructor
Michael W. Dong
is a principal in MWD Consulting. He was formerly Senior Scientist at Genentech, Research Fellow at Purdue Pharma, and Staff Scientist at Perkin-Elmer. He holds a Ph.D. in Analytical Chemistry from City University of New York and has 100+ publications and 3 books.