Achieving Equivalent Results When Transferring Methods While Using Different Vendor's Equipment

Validated analytical methods are often transferred across laboratories and to partners such as CROs and CMOs that are equipped with LC systems from different vendors. Additionally, if a new modern instrument is introduced into a laboratory, it must also be capable of replicating all the validated method’s performance attributes.

Migration of chromatographic methods between different LC systems, especially from different manufacturers, can be a challenging task. Often, these instruments have different system volumes, which may cause poor chromatographic separation and peak distortion in gradient methods. This may produce different results for the same analysis generated across instruments.

In this work, migration of an HPLC method for related substances analysis of aspirin API to an Arc HPLC system is presented. The equivalent performance is demonstrated by examining chromatographic separation, system suitability results and related substances assay results. We show that the Arc HPLC System successfully replicates methods, producing equivalent chromatographic separation and analytical results generated by the method to the results obtained on the comparable LC systems.