Quality by design in the chiral separation strategy for the determination of enantiomeric impurities: Development of a capillary electrophoresis method based on dual cyclodextrin systems for the analysis of levosulpiride

Orlandini, Serena; Pasquini, Benedetta; Bubba, Massimo Del; Pinzauti, S.; Furlanetto, Sandra

doi:10.1016/j.chroma.2014.12.065

Cited by 60 publications

(39 citation statements)

References 50 publications

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“…The CQAs requirements were a baseline separation between the critical peak pairs ( Rs 4 ≥ 3.0, Rs 5 ≥ 0.5), a good I 2 peak efficiency (Log N ≥ 5.5), and a low t ( t ≤ 5 min). The low Rs 5 target value depends on the fact that the separation refers to a pair of peaks of different characteristics of area and width, and was defined taking into account visual analysis of the electropherograms and previous experience .…”

Section: Resultsmentioning

confidence: 99%

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Analytical Quality by Design in pharmaceutical quality assurance: Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities

et al. 2015

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A fast and selective CE method for the determination of zolmitriptan (ZOL) and its five potential impurities has been developed applying the analytical Quality by Design principles. Voltage, temperature, buffer concentration, and pH were investigated as critical process parameters that can influence the critical quality attributes, represented by critical resolution values between peak pairs, analysis time, and peak efficiency of ZOL-dimer. A symmetric screening matrix was employed for investigating the knowledge space, and a Box-Behnken design was used to evaluate the main, interaction, and quadratic effects of the critical process parameters on the critical quality attributes. Contour plots were drawn highlighting important interactions between buffer concentration and pH, and the gained information was merged into the sweet spot plots. Design space (DS) was established by the combined use of response surface methodology and Monte Carlo simulations, introducing a probability concept and thus allowing the quality of the analytical performances to be assured in a defined domain. The working conditions (with the interval defining the DS) were as follows: BGE, 138 mM (115-150 mM) phosphate buffer pH 2.74 (2.54-2.94); temperature, 25°C (24-25°C); voltage, 30 kV. A control strategy was planned based on method robustness and system suitability criteria. The main advantages of applying the Quality by Design concept consisted of a great increase of knowledge of the analytical system, obtained throughout multivariate techniques, and of the achievement of analytical assurance of quality, derived by probability-based definition of DS. The developed method was finally validated and applied to the analysis of ZOL tablets.

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Section: Resultsmentioning

confidence: 99%

“…Nevertheless, up to now there is a negligible experience within the analytical QbD approach, and more discussions on QbD implementation are needed. The majority of methods which employ a QbD development regard chromatographic techniques , while a few papers have been dedicated to QbD development of CE methods .…”

Section: Introductionmentioning

confidence: 99%

Analytical Quality by Design in pharmaceutical quality assurance: Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities

et al. 2015

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“…Most publications are in the form of lectures and posters at industrial scientific meeting series like “CE in the Pharmaceutical and Biotech Industry” and “Analytical Technologies Europe” . The research papers that appeared since the previous review are all by the same group . These papers give excellent explanations on the DoE procedures used.…”

Section: General Considerations Of Ce Methods In Pharmaceutical Analysismentioning

confidence: 99%

“…Often, systems comprising a charged CD and an uncharged CD are used but combinations of two neutral CDs have also been reported as summarized, for example, in . Orlandini and coworkers combined sulfated β‐CD and methyl‐β‐CD (M‐β‐CD) for the analysis of the enantiomeric purity of S ‐configured levosulpiride . In this study, an AQbD approach was taken defining the accurate simultaneous determination of the main component and the chiral impurity in a short analysis time as the analytical target profile of the method.…”

Section: Separation and Analysis Of Small Moleculesmentioning

confidence: 99%

Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis (2013–2015)

et al. 2016

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This review updates and follows-up a previous review by highlighting recent advancements regarding capillary electromigration methodologies and applications in pharmaceutical analysis. General approaches such as quality by design as well as sample injection methods and detection sensitivity are discussed. The separation and analysis of drug-related substances, chiral CE, and chiral CE-MS in addition to the determination of physicochemical constants are addressed. The advantages of applying affinity capillary electrophoresis in studying receptor-ligand interactions are highlighted. Finally, current aspects related to the analysis of biopharmaceuticals are reviewed. The present review covers the literature between January 2013 and December 2015.

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“…peptides or for development of methods for enantiomeric purity determination (Mikuma et al, 2015;Orlandini et al, 2015;Rousseau et al, 2010).…”

Section: Discrimination Between Drug Enantiomersmentioning

confidence: 99%

Anionic cyclodextrins as versatile hosts for pharmaceutical nanotechnology: Synthesis, drug delivery, enantioselectivity, contrast agents for MRI

Mavridis

Yannakopoulou

2015

International Journal of Pharmaceutics

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Quality by design in the chiral separation strategy for the determination of enantiomeric impurities: Development of a capillary electrophoresis method based on dual cyclodextrin systems for the analysis of levosulpiride

Cited by 60 publications

References 50 publications

Analytical Quality by Design in pharmaceutical quality assurance: Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities

Analytical Quality by Design in pharmaceutical quality assurance: Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities

Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis (2013–2015)

Anionic cyclodextrins as versatile hosts for pharmaceutical nanotechnology: Synthesis, drug delivery, enantioselectivity, contrast agents for MRI

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