E14-14: Essentials of Modern HPLC/UHPLC 2

Essentials of Modern HPLC/UHPLC II: 
Operation, Troubleshooting and Method Development

E14-14: One-Day Course, Monday, November 17, 8:30am-5:00pm

 Dr. Michael W. Dong, Genentech, S. San Francisco, CA

This intermediate course will introduce you to best practices of high-performance liquid chromatography (HPLC) and ultra-high-pressure liquid chromatography (UHPLC) as well as tricks-of-the-trade and best practice 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 a section on UHPLC. This is the second part of a two-course series for modern HPLC introduction. “Essentials of Modern HPLC/UHPLC 1” introduces HPLC fundamental concepts, columns, instrumentations and applications, is a prerequisite for “Essentials of Modern HPLC/UHPLC 2”.

Analysts, scientists, researchers and managers who want to get an updated introduction of modern HPLC practices, instrument operation, maintenance, troubleshooting, method development as well as the practice and issues of UHPLC. A good understanding of general chemistry is recommended. Some prior hands-on HPLC experience will be helpful but not absolutely mandatory. “Essentials of Modern HPLC/UHPLC 1” is a prerequisite to “Essentials of Modern HPLC/UHPLC2” for newer users. This course is conducted at an advanced beginner or intermediate level

1. HPLC Operation, Maintenance and Troubleshooting
     * Mobile phase preparation
     * Best practice in HPLC operation 
     * Guidelines for increasing HPLC precision and for trace analysis
     * Seven common “faux pas” in modern HPLC
     * Common HPLC maintenance procedures
     * Problem diagnosis and troubleshooting guide with case studies
     * Diagnosing and solving problems (pressure, baseline, peak, data performance)
2. HPLC Method Development and Validation
     * Tradition strategy for HPLC method development
     * 3-pronged template approach for efficient method development
     * Method prequalification and validation
     * Modern trends – software tools and automated systems
     * Case studies on developing ICH impurity testing of pharmaceuticals including some discussions on phase-appropriate method development concepts
3. Ultra High-Pressure LC 1 – Concepts, Perspectives, and Benefits
     * History and current status of UHPLC
     * Practical concepts and instrumental considerations
     * Benefits: very fast separation with good resolution, very high resolution of complex samples, facilitating rapid method development
     * Case studies (NCE, OTC, complex molecules and natural products)
4. Ultra High-Pressure LC 2 – Practice, Potential Issues and QC Implementation
     * Potential issues and operating nuances (viscous heating, system dispersion, compatibility to existing methods, injection precision and carryover, detector sensitivity and dwell volumes, and method transfer issues)
     * Case studies illustrating issues and myths, and how to mitigate potential pitfalls
     * How to get started and to transition from HPLC to UHPLC

M. W. Dong, Modern HPLC for Practicing Scientists, Wiley-Interscience, New Jersey, 2006 (ISBN-10: 047172789X). This book is used as a course reference and supplements the course presentation handouts.

Dr. Michael W. Dong is a Senior Scientist at Genentech, Small Molecule Drug Discovery, South San Francisco, CA. He is responsible for new technologies, automation and supporting multiple late-stage research projects in Small Molecule Analytical Chemistry and Quality Control, Small Molecule Pharmaceutical Sciences. He was formerly Research Director at Synomics Pharma, Research Fellow at Purdue Pharma, Senior Staff Scientist at Applied Biosystems / Perkin-Elmer, and section-head in Hoechst Celanese. He holds a Ph.D. in Analytical Chemistry from City University of New York, and a certificate in Biotechnology at U. California. Santa Cruz. He has conducted training courses at national meetings (ACS, Pittcon, EAS, HPLC) on HPLC in pharmaceutical analysis, HPLC method development, ultra-high-pressure LC, drug development process for scientists, and drug quality fundamentals. He has over 100 publications in chromatography and analytical chemistry. He authored a best-seller in chromatography – Modern HPLC for Practicing Scientists, Wiley, 2006 and co-edited Handbook of Pharmaceutical Analysis by HPLC, Elsevier/Academic Press, 2005. He is an editorial advisory board member of LCGC magazine and American Pharmaceutical Review.