Abstract
There are several different approaches for LC method development; beside traditional, different software programs for method development and optimization are available. The solvatic retention model of reversed-phase LC was applied for prediction of retention in the gradient elution mode for aripiprazole and its related substances described in European Pharmacopoeia. As some of these compounds have very similar and others quite different chemical structure, their separation is challenge. Prediction was suitable on examined stationary phases (C18, C8 and phenyl-hexyl) with 0.1% phosphoric acid as aqueous mobile phase and acetonitrile or methanol as organic modifier. Predicted retention times take into account structural formulae of compounds and properties of stationary and mobile phases result in average difference of 14-17% compared to experimental ones on phenyl-hexyl stationary phase, where the highest matching was obtained. After utilisation of the retention models with data from one experimental run, the average difference decrease to maximal 7% and after contribution of data from two experimental runs, to maximal 2%. For majority of studied compounds difference between predicted and experimental values on all examined stationary phases is lower than 3%.
Highlights
As development and optimization of HPLC methods can be very time-consuming,[1,2] for rapid method development a systematic, automated approach is needed.[3]
Predicted retention times take into account structural formulae of compounds and properties of stationary and mobile phases result in average difference of 14–17% compared to experimental ones on phenyl-hexyl stationary phase, where the highest matching was obtained
The solvatic retention model in reversed-phase HPLC for retention prediction in gradient elution mode, using different types of stationary phases (C18, C8 and phenyl-hexyl) was applied for aripiprazole and its related substances described in European Pharmacopoeia
Summary
As development and optimization of HPLC methods can be very time-consuming,[1,2] for rapid method development a systematic, automated approach is needed.[3]. G. active pharmaceutical compound with typical impurities) and evaluation of the results.[4] Presumably methods developed using computer-assisted procedures are expected to be more robust than those, developed by the traditional »trial and error« approach.[5,6,7] Three main factors affect analyte partition between the stationary and the mobile phase. Those are the chemical structure of analyte, characteristics of the stationary phase and physico-chemical properties of the mobile phase at the constant temperature.[8] Several software programs for method development and method optimization are available – ACD/LC simulator®, ChromSmart®, ChromSword®, DryLab®, Osiris®, Preopt-W® and others. In 2003, Baczek and Kaliszan applied quantitative structure retention relationships (QSRRs) to predict retention in reversed-phase HPLC with linear gradient.[19]
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