Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient.
Like the majority of pharmacopeial LC methods, the chromatographic analysis of temozolomide and its four related impurities given by European and United States Pharmacopeia relies on reversed-phase separation. However, the analytes are very hydrophilic, and the method is based on highly aqueous mobile phase and ion-pairing reagents. Thus, hydrophilic interaction liquid chromatography (HILIC) appears as a convenient alternative. In the current work, a new HILIC method was set up and was successfully transferred from an Agilent 1260 Infinity LC (1260 Infinity) system to a Vanquish Core HPLC.
The straightforward transfer from a Shimadzu Nexera-i system to a Thermo Scientific Vanquish Core HPLC system is demonstrated for the EP method for chlorhexidine impurity analysis. Equivalent chromatographic outcomes are provided by the two systems with improved system precision of the Vanquish Core HPLC system. Small deviations of absolute retention times due to different system gradient delay volumes were easily decreased by an adjustment of the idle volume of the Vanquish Core autosampler.
Reliable and highly reproducible chromatographic results were obtained when implementing the liquid chromatography-based impurity method from the Ph. Eur. monograph of metolazone.
Straightforward transfer of an EP monograph HPLC method from a Thermo Scientific™ UltiMate™ 3000 Standard HPLC system to a Thermo Scientific™ Vanquish™ Core HPLC system is demonstrated. Equivalent chromatographic results are obtained with both systems, but an improved resolution and retention time stability are provided by the Vanquish Core HPLC system.
