One–Day Course
Sunday, Nov. 12; 8:30am – 5:00pm

Dr. Michael W. Dong, MWD Consulting, Norwalk, CT

COURSE DESCRIPTION
This intermediate course will provide the analytical scientist with a clearer understanding and a solid working knowledge of the concepts, instrumentation, columns, applications, and best practices in method development and troubleshooting of HPLC and UHPLC (ultra-high-pressure liquid chromatography).  The focus is on pharmaceutical analysis of small molecule drugs. This is Part 1 of a two-day course.

WHO SHOULD ATTEND
Analysts, scientists, researchers, and managers in pharmaceutical and other industries who want to get an updated overview of fundamentals and best practice of modern HPLC/UHPLC in pharmaceutical analysis and other applications including HPLC method development, operation and troubleshooting.  A basic understanding of chemistry and HPLC with some hands-on experience is assumed.

Day 1: HPLC 1: Fundamentals:

1. Concepts
   a. Introduction: The chromatographic process, advantages and limitations, and chromatographic modes (NPC, RPC, IEC, SEC)
   b. Concepts: Retention factor (k), separation factor (a), column efficiency (N), resolution (R_s), tailing factor (T_f), the resolution equation, the linear solvent strength theory, and column void volume (V_M)
   c. Mobile phase factors (organic modifiers, pH, buffers), mass spec compatibility, isocratic and gradient separations, operating parameters (Flow, gradient time (t_G), column temperature (T)), peak capacity (P_c)
2. HPLC Columns, Trends and Selection Guides
   a. Column fundamentals: Glossary, Characteristics, and types, packing characteristics (support type, particle size, pore size), bonded phases, end-fittings, plate height (H), the van Deemter equation
   b. Trends: Trends of shorter and smaller columns and the use of high-purity silica, traditional and novel bonding chemistries, concept of “orthogonality,”  listing of common RPC columns, column selection guide
   c. Newer column types: Hybrids, charged surface hybrids, HILIC, sub-3 and sub-2 mm, and superficially porous particles (SPP)
3. HPLC Instrumentation and Operating Principles
   a. System, Pump, and Autosampler. Integrated vs. modular system, solvent delivery system, low-pressure vs. high-pressure mixing, dwell volume, pump trends, autosampler types and trends
   b. Detectors: Operating principles of UV/Vis detection and characteristics, photodiode array detector (DAD), newer detectors for non-chromophoric analytes (ELSD, CAD, and CLND)
   c. MS, CDS, and Instrument Bandwidth. The mass spectrometer (MS), types and ESI interface, Data Chromatography System (CDS), peak integration strategy, instrumental bandwidth

ABOUT THE INSTRUCTOR
Dr. Michael W. Dong is a principal of MWD Consulting

focusing on consulting and training services on HPLC, pharmaceutical analysis, and drug quality.  He was formerly a Senior Scientist in Analytical Chemistry and Quality Control at Genentech,  Research Fellow at Purdue Pharma, and Senior Staff Scientist at Applied Biosystems/Perkin-Elmer. He holds a Ph.D. in Analytical Chemistry from the City University of New York and a certificate in Biotechnology from the University of California Santa Cruz.  He has 130+ publications and five books, including a bestselling book on chromatography (HPLC and UHPLC for Practicing Scientists, 2^nd Ed., Wiley, 2019).  He is an advisory board member of LCGC magazine and the Chinese American Chromatography Association.  He has been a columnist for “Perspectives of Modern HPLC” for LCGC North America since 2013.  Michael was born in Shanghai and raised in Hong Kong.  He is multilingual, an Eagle Scout, and a long-term Toastmaster.