Renewal of an old European Pharmacopoeia method for Terazosin using modeling with mass spectrometric peak tracking

摘要

An older method for terazosin was reworked in order to reduce the analysis time from 90 min (2 x 45 min) to below 5 min. The method in European Pharmacopoeia (Ph.Eur.) investigates the specified impurities separately. The reason of the different methods is that the retention of two impurities is not adequate in reversed phase, not even with 100% water. Therefore ion-pair-chromatography has to be applied and since that two impurities absorb at low UV-wavelength they had to be analyzed by different method than the other specified impurities. In our new method we could improve the retention with pH elevation using a new type of stationary phases available for high pH applications. Also a detection wavelength could be selected that is appropriate for the detection and quantification of all impurities.