A very popular, on-demand webinar discussed in this blog post, Improve Your Workflow for Linearity Testing using Automated Sample Preparation & UHPLC, was presented by Dr. Fraser McLeod (Thermo Fisher Scientific) and and Dr. Joanne Ratcliff (Mettler-Toledo Corporation) last year. We recently received the recording from our vendor and thought it would be great to share it embedded in this blog post.
Dr. McLeod and Dr. Ratcliff discuss the use of integrated technologies developed by both companies which can streamline the workflow process of sample preparation, analysis, and reporting of pharmaceutical preparations as per the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. (The ICH defines guidelines for linearity testing, sample preparation, method validation, and analysis of pharmaceutical formulations in the European Union.)
The workflow discussed during the course of the webinar is broken into three sections and demonstrates how each step of the process has been refined and accelerated while adhering to the strict requirements of the ICH. Also, the automated gravimetric measurement of standards demonstrated by the Mettler-Toledo Quantos system demonstrated better accuracy than traditional volumetric measurement while saving time.
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The instrument used for chromatographic analysis was the Thermo Scientific Dionex Basic Automated UHPLC system which can perform routine HPLC analyses and can operate at pressures up to 620 bar and 10 mL /min; these specifications are the entry points to UHPLC.
The presenters also discuss tips for data evaluation, comparison of results to standards, and presentation of results using a Chromatography Data System (CDS) software (in this instance the Thermo Scientific Dionex Chromeleon CDS software). The Chromeleon CDS software performed peak integration, transfer of concentrations and peaks to a report format, calculated parameters related to the analysis, and created a customized report in less than 5 minutes! In addition, the results show correlation coefficients greater than .9995 for all analytes and in some cases .9999! This exceeds even the stringent accuracy and precision requirements of the ICH.
In summary, using the automated workflow shown here, sample preparation time is reduced from 180 min to 50 min; analysis time is reduced from 450 min to 75 min, and reporting results is reduced to 5 min from 120. The entire process therefore, is accelerated by a factor of 6.2, and demonstrates better precision and accuracy than traditional workflow for pharmaceuticals!
Are you interested in learning how you can customize and streamline your chromatography workflows while improving your accuracy? Let us know in the Comments section below.