Robust method optimization strategy—A useful tool for method transfer: The case of SFC

Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles

“…In this paper we aimed to compare two approaches. First approach was to assess model uncertainty propagating the error equal to the variance of the residuals [8,9] when the error distribution was added to the mean predicted responses in order to obtain responses' distribution for each operating condition corresponding to a grid point. Second approach consisted in propagating the error in model coefficients' calculation [4] when the error distribution equal to the calculated standard error was added to the model coefficient estimates in order to obtain responses' distribution for each operating condition corresponding to a grid point.…”

“…The robust optimization approach provides the assurance of the method quality represented by such DS which can be considered a "safe zone" where no significant changes of the CQAs levels should be observed as a consequence of small, deliberate changes of method parameters. In the literature several examples of the QbD approach in the development of liquid chromatographic methods could be found [4][5][6][7][8][9].…”

Development of liquid chromatographic method for the analysis of dabigatran etexilate mesilate and its ten impurities supported by quality-by-design methodology

“…For that reason the aim of this research was to develop liquid chromatographic method in the most efficient way. As a very useful tool for the development of robust and reliable analytical method, the quality-by-design (QbD) methodology, known from production processes has been adapted to analytical methods [7] and applied by several authors in the liquid chromatographic [8][9][10][11][12][13][14], super critical fluid chromatographic [15] and solvent-modified micellar electrokinetic chromatographic [16] method development. The development of a QbD compliant analytical method is focused on establishment of comprehensive design space (DS) which can be further analyzed to determine the optimal working conditions.…”

The successful binomium of multivariate strategies and electrophoresis for the Quality by Design separation of a class of drugs: the case of triptans

“…QbD includes all aspects and advantages of multivariate techniques, adding a concept of probability. By following this approach, an in‐depth understanding of the method is achieved and the final outcome is the development of robust methods and the possibility of smooth analytical method transfer .…”