Transfer of USP-based HPLC Methods for Pantoprazole Sodium to UPLC: 20-fold Increase in Productivity

摘要

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. The USP methods for assay and purity of the active pharmaceutical ingredient pantoprazole sodium, were successfully transferred from the USP-recommended L1 column on a conventional HPLC system, to a small particle 1.7 (mu)m column on a UPLC system, while the system suitability criteria of the USP monograph are still met.