(u)HPLC Method Development Made Easy: A New Short Course for Pittcon
This 1/2 day Pittcon short course is designed for those who develop HPLC methods for stability-indicating, potency and other purity assays. It reviews the traditional approach according to Snyder and introduces a 3-pronged template approach for rapid development as well as an even simpler modernized generic universal gradient method approach. For those developing method for complex samples, a QbD/DoE approach using an automated software platform may be the most expeditious.
Link to registration: http://pittcon.org/short-courses/#fees
Agenda is shown below:
HPLC/UHPLC Method Development Made Easy, Dr. Michael W. Dong, Norwalk CT, USA (1/2 day), michael@mwd-consulting.com
Course description
This 1/2-day workshop reviews best practices, short cuts and tricks-of-the-trade to help the pharmaceutical or other analytical scientists to become more successful in developing effective HPLC/UHPLC methods (potency and ICH-compliant stability-indicating assays) using the traditional approach, a 3-pronged method template approach, a universal generic gradient method(s) and a QbD approach using automation and statistical software tools.
Target Audience
This workshop is intended for analysts, managers, and researchers using HPLC or UHPLC in the pharmaceutical and other laboratories wishing to learn how to develop HPLC methods quickly and more effectively using the traditional and other expedited approaches. A fundamental understanding of HPLC is assumed and some practical hands-on HPLC experience is highly recommended.
Workshop Agenda
A. The Traditional Method Development Approach
a. Glossary, Insights, 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
b. General method development strategy, forced degradation studies to demonstrate method specificity, method development trends, Phase-appropriate method development, development of secondary “orthogonal” methods, automation screening systems and software tools, Fusion QbD.
B. The 3-Pronged Template Approach for Rapid Method Development
a. Fast LC isocratic methods for potency or performance assessment,
generic broad-gradient methods for in-process control, high-throughput screening, purity assays of starting materials and cleaning verification
Multi-segment gradient methods for ICH compliant stability-indicating assays of complex molecules, case studies of multichiral drugs and complex products with multiple APIs, references
C. A Modern Universal Generic Gradient Method(s):
a. Introduction of a universal generic gradient method(s), This fast LC method is capable of peak capacities of 100-300 in 2 to 5 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.
D. Quality by Design (QbD) Approach to method development:
a. Introduction to QbD, Design of Experiments (DoE), and ICH Q8(R2), QbD approach to HPLC method development using S-Matrix Fusion QbD software platform
b. Case Studies 1 to 4 illustrating workflows and results
Learning Outcomes for HPLC/UHPLC Method Development Made Easy
The pharmaceutical scientist will get a critical overview of the traditional HPLC method development strategy supplemented by a quicker 3-pronged template approach for rapid method development, the use of a universal generic gradient method for multiple new chemical entities and a QbD approach to method development using S-Matrix Fusion QbD software for automated system control and statistical data analysis.
Biography
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). He is an editorial advisory board member of LCGC magazine and American Pharmaceutical Review.
Recommended textbook:
M. W. Dong, Modern HPLC for Practicing Scientists, Wiley-Interscience, New Jersey, 2006 (ISBN-10: 047172789X).
