Transfer of USP-based HPLC Methods for Pantoprazole Sodium to UPLC

20-fold Increase in Productivity

HPLC is a commonly used analytical method for assaying and purity controlling of active pharmaceutical ingredients („API's") in the pharmaceutical industry. Method transfer to the latest technologies can be time-consuming and are therefore rarely performed for the improvement of validated methods. However, the transfer of established methods to a UPLC (ultra performance liquid chromatography) system can be worth the investment. In the reported case such an investment was rewarded with surprising savings in analysis time, operational costs and improved resolution.

We demonstrate the successful method transfer for the analysis of pantoprazole sodium from the USP-recommended L1 column, run on a conventional HPLC system, to a sub 2 µm particle column on a UPLC system. With some small optimization changes, the final methodology reduced the analysis run time from 55 min with HPLC to just 3 min with UPLC, resulting in a 20-fold increase in throughput and a remarkable reduction in solvent consumption and waste disposal costs.

Instruments being used are manufactured by Waters Corporation

Authors

Contact

Steiner & Co. Deutsche Arzneimittelgesellschaft
Wallenroder Straße 12 - 14
13435 Berlin
Phone: +49 30 710 94 4200
Telefax: +49 30 710 94 4250

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