Application Note

BEH C18 Batch-To-Batch Robustness For The Analysis Of Rosuvastatin And Impurities

By Fadi L. Alkhateeb, Kevin M. Jenkins, Paul D. Rainville

PIlls Blister Packaging GettyImages-174777552

The goal of a method development process is to find a well-working and robust method that consistently delivers the expected performance throughout its lifecycle. This process can be very complex and time consuming, especially if multiple chromatographic parameters need to be explored. Column reproducibility is a key parameter that has a critical impact on the long-term reliability and robustness of such analytical methods. This is because column-to-column and batch-to-batch variability can result in unacceptable chromatographic performance that could require the method to be revalidated for regulatory acceptance. As such, it is crucial to select columns that are rugged and reproducible when developing analytical methods to reduce the risk of having out-of-specification and out-of-trend results throughout the method life.

The main goal of this study is to investigate the long-term batch-to-batch reproducibility of 10 different lots of XBridge BEH C18 Columns.

There are five paramount parameters to consider when evaluating batch-to-batch reproducibility of columns: relative retention time, critical pair resolution, peak symmetry, column efficiency (plate count), and batch-to-batch consistency.

This application note demonstrates the robustness of XBridge BEH C18 Columns when used for the analysis of rosuvastatin and impurities.

Continue reading to discover the findings of this study.

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