My very First Pittcon Webinar on “(u)HPLC Method Development Made Easy” – Focusing on stability-indicating assays

While I have been giving HPLC short course at Pittcon for almost 20 years, this November 15 will be the date for my first Pittcon Webinar. The goal is to showcase the quality and contents of the longer on-site HPLC short course upcoming in Chicago in March of 2020. 

I have recently revised the title and content as shown in the webinar agenda below. The cost is only $199 for this 2-hour plus 30 minutes of Q&A. Registrant will also be entitled to a $100 discount for any short courses taken at Pittcon 2020 in Chicago.

Registration link is open now with an introductory video on the benfits of this webinar. Questions/comments are welcomed to [email protected]

https://pittcon.org/short-courses/online/

link to the Youtube introductory video

https://www.youtube.com/watch?v=PdOeCFnr58M&feature=youtu.be

 u)HPLC Method Development Made Easy

(Focusing on Stability-Indicating Assays)  

Dr. Michael W. Dong, Norwalk CT, USA (2-hour plus 30-min Q&A), [email protected]

Course description

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.

 Webinar Agenda: (u)HPLC Method Development Made Easy

 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.   

Biography

Dr. Michael W. Dong is a principal consultant in MWD Consulting, focusing on consulting and training services on HPLC, 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 has 120+ publications, including a bestselling book on chromatography (HPLC and UHPLC for Practicing Scientists, 2nd Ed., Wiley, 2019). He is an advisory board member of LCGC magazine, American Pharmaceutical Review, and Chinese American Chromatography Association. He has been a columnist of “Perspectives of Modern HPLC” for LCGC North America since 2013.  

Recommended Textbook:

M. W. Dong, HPLC and UHPLC for Practicing Scientists, 2nd Ed., Wiley, Hoboken, New Jersey, 2019. This bestseller HPLC book has a list price of $99.95 and can be purchased by the attendees at Amazon.com at a substantial discount for either the paperback or e-book version.