Date is TBA; 8:30am – 5:00pm
Dr. Michael W. Dong, MWD Consulting, Foster City, CA
This intermediate 1-day workshop will provide the analytical scientist with a clearer understanding and a solid working knowledge of the concepts, instrumentation, columns, and pharmaceutical applications of modern HPLC and UHPLC (ultra-high-pressure liquid chromatography). The focus is on its practice in pharmaceutical analysis of small molecule drug substances and drug products.
Modern HPLC/UHPLC for Practicing Scientists Part 2: Pharmaceutical Applications, UHPLC, Method Development and Troubleshooting is the second part of this two-day course. Part 1 and 2 can be combined as a two-day course; a discount will be offered over separately registering for the two one-day courses. (click here for Part 2 course description)
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. A basic understanding of chemistry and HPLC with some hands-on experience is assumed.
1. Modern 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 (Rs), tailing factor (Tf), the resolution equation, the linear solvent strength theory, and column void volume (VM)
c. Mobile phase factors (organic modifiers, pH, buffers), mass spec compatibility, isocratic and gradient separations, operating parameters (Flow, gradient time (tG), column temperature (T)), peak capacity (Pc), references
2. HPLC Columns, Trends and Selection Guides
a. Column fundamentals: Glossary and abbreviation, Characteristics and types, packing characteristics (support type, particle size, pore size), bonded phases, end-fittings, plate height (H), the van Deemter equation, and an estimation of column efficiency
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-2mm, and superficially porous particles (SPP), References
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 and ramification, pump trends, manual injection valve, autosampler types and trends
b. Detectors: Operating principles of UV/Vis detection and characteristics, monitoring wavelength selection, photodiode array detector (DAD), newer detectors for non-chromophoric analytes (ELSD, CAD and CLND), applications of CAD
c. MS, CDS and Instrument Bandwidth. Mass spectrometer (MS), types and ESI interface, data handling system (CDS). steps in sample analysis, concept of instrumental bandwidth (extra-column bandbroadening), loss of column efficiency vs. column size
4. Pharmaceutical Analysis of Small Molecule Drugs
a. A brief overview of pharmaceutical discovery/development, Chemistry, Manufacturing and Control (CMC), analytical development and quality control in small molecule drugs development, potency assay, stability-indicating method, stability study, dissolution testing, chiral separations, and certificates of analysis of drug substance and reference materials, OTC products with multiple actives, herbal products, pharmaceutical counterions and excipients.
ABOUT THE INSTRUCTOR
Dr. Michael W. Dong is a principal consultant in MWD Consulting focusing on consulting and training services on HPLC/UHPLC, pharmaceutical analysis, and drug quality. He was formerly Senior Scientist in Analytical Chemistry and Quality Control at Genentech, Research Director at Synomics Pharma, 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 U. C. Santa Cruz. He has 100+ publications including a bestselling book on chromatography (Modern HPLC for Practicing Scientists, Wiley). He is an editorial advisory board member of LCGC magazine, American Pharmaceutical Review, and Chinese American Chromatography Association.