Short Course Webinar: (u)HPLC Method Development Made Easy
Focusing on Stability-Indicating Assays
November 15, 2019 (9:00 am to 11:00 am EST)
This 2-hour intermediate webinar reviews best practices, short cuts, and tricks-of-the-trade to help pharmaceutical and other scientists to become more successful in developing effective HPLC methods (focuses on potency and ICH-compliant stability-indicating assays of pharmaceuticals) using a 3-pronged method template and universal generic gradient method(s) approaches.
Who Should Attend?
This webinar is intended for analysts, managers, and researchers using HPLC in the pharmaceutical laboratory and other industries wishing to learn how to develop HPLC methods quickly and more effectively. A fundamental understanding of HPLC is assumed, and some practical hands-on HPLC and method development experience is highly recommended.
HPLC and UHPLC for Practicing Scientist – LEARN MORE
Why Should You Take This Course?
Dr. Michael Dong explains the benefits of taking his course.
A. Overview and Back to the Basics
► Why focus on stability-indicating assays of pharmaceuticals?
► Why gradient RPC with UV detection and acidic mobile phases?
► Some HPLC method development insights…
B. The Traditional Approach according to Snyder, Kirkland and Glajch
► Steps in traditional method development, Scouting gradient and getting the first chromatogram, method fine-tuning and optimization (Solvent strength/type, pH, buffer/additive, F, T, tG), Case studies for method development of a phase 0 method for a new chemical entity
► General method development strategy, forced degradation studies to demonstrate method specificity, automation screening systems, and software tools
C. The 3-Pronged Template Approach for Rapid Method Development
► Fast LC isocratic methods for potency or performance assessment, generic broad-gradient methods, Multi-segment gradient methods for ICH compliant stability-indicating assays of complex molecules, case studies of multi-chiral drugs and complex products with multiple APIs, references
D. A Modern Universal Generic Gradient Method(s):
► Introduction of a universal generic gradient method(s), method is capable of peak capacities of 100-300 in 2 to 6 minutes, Rationales of selection of column and operating conditions (CSH, SPP, tG), method adjustments, Case studies for cleaning verification of multiple NCEs, purity assays including compounds with multiple chiral centers
Dr. Michael Dong Bio
Dr. Michael W. Dong is a principal in MWD Consulting focusing on training and consulting services in HPLC/UHPLC, pharm analysis, and drug quality. He was formerly Senior Scientist 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 City University of New York, and a certificate in Biotechnology at U. California. Santa Cruz. He has over 120 publications and a best-seller book in HPLC. He is an advisory board member of LCGC magazine, American Pharmaceutical Review, and Chinese American Chromatography Association.
HPLC and UHPLC for Practicing Scientists
2nd Ed., Wiley, Hoboken, New Jersey, 2019
Textbook can be purchased online. Paperback or e-book versions are available for a discount at Amazon.