|
||
| Check out these recent articles from LCGC on applying Quality by Design to HPLC methods for pharmaceutical analysis. Rapid UHPLC Method Development for Omeprazole Analysis in a Quality-by-Design Framework and Transfer to HPLC Using Chromatographic Modeling The aim of this study was to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatography (UHPLC) method for omeprazole and its related impurities. Rapid UHPLC Method Development for Omeprazole Analysis in a Quality-by-Design Framework and Transfer to HPLC Using Chromatographic Modeling A new type of method development that uses modeling to find the "best" separation for high performance liquid chromatography (HPLC) was investigated and principles of Quality by Design (QbD) were followed when planning the investigation. The process delivered precise results and the method was able be transferred to a routine quality control (QC) laboratory.  A New Method for Quality by Design Robust Optimization in Liquid Chromatography A new method to optimize liquid chromatography (LC) methods using a Quality by Design (QbD) approach is presented. This method is based on the use of design of experiments (DOE) and independent component analysis (ICA) to accurately estimate the modeled responses (that is, the retention times at the beginning, the apex, and the end) of each peak, even for coeluted peaks. This method was applied to the optimization of the separation of nine compounds in a mixture, yielding the design space and the demonstration of robustness of the method. Interview: Analytical Quality by Design in the Pharmaceutical Industry As Quality by Design has become a more established approach in pharmaceutical development and manufacturing, more companies are now integrating the concept into analytical method development. LCGC spoke to Rosario LoBrutto of Teva about the business of analytical QbD, the steps involved in implementing it, and advice to those who want to get started. Coming up in the May issue of LCGC: Quality by Design in Pharmaceutical Analysis Using Computer Simulation with UPLC Technology Róbert Kormány, Imre Molnár, and Jenö Fekete |
||
