The focus of this post to present several resources for troubleshooting UHPLC and HPLC methods in pharmaceutical and biopharmaceutical applications. How this post came about was with my receiving the first resource via an email and then learning about the webinar.
First, a robust, user-friendly, and fast generic approach for troubleshooting pharmaceutical HPLC and UHPLC assays that was presented at last year's HPLC conference by our software experts from Germering, Germany, and Chelmsford, (USA). For the development of the troubleshooting method, as described in Poster Note, Developing a Guided Procedure for Troubleshooting HPLC and UHPLC Systems, (downloadable PDF), the experts separated isocratic and gradient test mixtures on a reference column to assess the performance of the instrument and separation column. They also identified identify key parameters of chromatographic performance using standardized test mixes run with standardized reference methods and a selected reference column. The goal of experiment was to clearly distinguish between instrument and chemistry issues and to automate the troubleshooting reccomendations in a customized report provided by the lastest version of our Chromatography Data System (CDS) software (Thermo Scientific Dionex Chromeleon CDS software Version 7.2).
The method was developed on the pharma drug nevirapine, a non-nucleoside reverse transcriptase-inhibitor with activity against human immunodeficiency virus type 1 (HIV-1).
Another resource that might be useful is a recent, on-demand webinar, Going Beyond Performance Limitations in UHPLC for the Utmost Analytical Benefit, (link to short registration page before you can play the webinar) where our experts discuss how UHPLC can be optimized for analysis speed, resolution and peak capacity; how to select the best column for your analysis; and, pharma and biopharma analysis examples.
If you've been working with HPLC for any length of time, you certainly have some troubleshooting war stories of your own. What's the toughest technical problem you ever solved, and what was the key that unlocked your solution? Tell us in the Comments box below. We look forward to hearing from you!