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How to Manage Analytical Methods Across all Stages of their Lifecycle Using One Chromatographic Modeling Tool
Dr. Imre Molnár (Founder and President) and Dr. Hans-Jürgen Rieger (Vice President, Product Management): Molnár-Institute for Applied Chromatography
This White Paper from Molnár Institute summarizes the content of a recent webcast and shows how chromatographic modeling using DryLab®4 software can save time and resources across all three stages of the lifecycle of an analytical method. Method run time can easily be reduced 40-fold with improved selectivity when redesigning an old method, simultaneously reducing the development time by a factor of 12. US Pharmacopeia (USP) methods that frequently fail can be fixed in accordance with allowed changes (USP 621) using DryLab4.
Chromatographic modeling can safeguard method robustness across the lifecycle for compendial methods, new method development, method transfers, and methods that fail in routine use, such as trading and continuous improvement.
The paper covers the three stage lifecycle management of analytical methods; Design, Qualification and Continued Verification, showing how methods design can establish a range of parameters within which the method performs as intended and within which the method is fit for use. DryLab4 software from Molnár Institute can optimize the performance of an existing method in three simple steps: input runs, peak tracking, and model creation, identifying the most robust separation within the existing design space.
The paper goes on to summarise a case study, modernizing compendial methods for ebastine. The traditional method, based on European Pharmacopeia description, was unfit for purpose because it was too long and could not keep up with production.
DryLab was used to reduce the analysis time from 160 minutes to less than three minutes. Development of the new method, now accepted in five countries, took less than two weeks.
A further case study focuses on improving the routine method for amlodipine, reducing it from the 45-60 minute isocratic procedure described in the European Pharmacopeia to a new model based on temperature peaks and gradient time selection that enabled researchers to evaluate resolution and robustness across a range of critical separation parameters. Use of DryLab combined with ultra-high pressure liquid chromatography resulted in a robust method with a less than six-minute run time.
Using DryLab for method robustness
The paper then explains how DryLab can be used to safeguard method robustness, enabling an experimental matrix to be constructed that recognizes the cumulative effect of multiple factors and baseline separated chromatograms that aid good resolution by more reliably integrating and quantifying peaks. Using DryLab, researchers are able to work within the method design space, to be compliant with both the system suitability test and the defined ATP method expectations.
In summary, the White Paper shows how DryLab can reliably model analytical methods, with good agreement between predicted and experimental chromatograms, opening up new approaches based on Visual Chromatography Modeling that can enable production laboratories to adjust methods readily at the end of their lifecycle to eliminate OoS results and improve productivity.