ReviewMolecules (Basel, Switzerland)2022
New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods.
Review in Molecules (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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Who cites it
18 citing papers in PubMed.
- Capillary Electrophoretic Enantioseparation of Profens: Advances in Chiral Selectors, Separation Strategies, and Analytical Applications.Molecules (Basel, Switzerland) · 2026Review
- Cyclodextrins as Chiral Selectors in Capillary Electrophoresis-Recent Developments in Understanding Analyte Complexation and Applications in Pharmaceutical Analysis.Electrophoresis · 2026Review
- Predicting enantiomer migration order of levobunolol via sequential computational modeling.Journal of molecular modeling · 2026Article
- A multi-metric evaluation of a sustainable capillary electrophoresis method for simultaneous therapeutic drug monitoring of Nilotinib and Ofloxacin in oncology clinics.Scientific reports · 2026Article
- Article
- Characterisation of Antisense Oligonucleotides by Ion-Pair Reversed-Phase UHPLC-HRMS: Method development using Design of Experiments.Journal of mass spectrometry : JMS · 2026Article
- Toward AI-Assisted Greener Chiral HPLC: Predicting Efficient Enantioseparation-Mobile Phase (EES-MP) Profiles for MP Selection─A Lux Cellulose-1 Case Study.Analytical chemistry · 2026Article
- Cyclodextrins as Chiral Selectors in Capillary Electromigration Techniques.Methods in molecular biology (Clifton, N.J.) · 2026Article
- A computational study on the enantioselective separation of cyhalothrin enantiomers by β-cyclodextrins.Journal of molecular modeling · 2025Article
- A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development.Electrophoresis · 2025Article
- Cyclodextrin-Modified Capillary Zone Electrophoresis for the Chiral Analysis of Proline and Hydroxyproline Stereoisomers in Chicken Collagen Hydrolysates.International journal of molecular sciences · 2025Article
- Determination of Enantiomeric Excess in Confined Aprotic Solvent.ACS electrochemistry · 2025Article
- Article
- Molecularly Imprinted Ratiometric Fluorescent Sensors for Analysis of Pharmaceuticals and Biomarkers.Sensors (Basel, Switzerland) · 2024Review
- Fast and precise chiroptical spectroscopy by photoelectron elliptical dichroism.Physical chemistry chemical physics : PCCP · 2023Article
- Analytical Quality by Design-Compliant Development of a Cyclodextrin-Modified Micellar ElectroKinetic Chromatography Method for the Determination of Trimecaine and Its Impurities.Molecules (Basel, Switzerland) · 2023Article
- Chiral Separation of Apremilast by Capillary Electrophoresis Using Succinyl-β-Cyclodextrin-Reversal of Enantiomer Elution Order by Cationic Capillary Coating.Molecules (Basel, Switzerland) · 2023Article
- Simultaneous Determination of Escitalopram Impurities including theMolecules (Basel, Switzerland) · 2022Article
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Authors and funding
7 authors.
Funding
Abstract
Capillary electrophoresis (CE) is a potent method for analyzing chiral substances and is commonly used in the enantioseparation and chiral purity control of pharmaceuticals from different matrices. The adoption of Quality by Design (QbD) concepts in analytical method development, optimization and validation is a widespread trend observed in various analytical approaches including chiral CE. The application of Analytical QbD (AQbD) leads to the development of analytical methods based on sound science combined with risk management, and to a well understood process clarifying the influence of method parameters on the analytical output. The Design of Experiments (DoE) method employing chemometric tools is an essential part of QbD-based method development, allowing for the simultaneous evaluation of experimental parameters as well as their interaction. In 2022 the International Council for Harmonization (ICH) released two draft guidelines (ICH Q14 and ICH Q2(R2)) that are intended to encourage more robust analytical procedures. The ICH Q14 guideline intends to harmonize the scientific approaches for analytical procedures' development, while the Q2(R2) document covers the validation principles for the use of analytical procedures including the recent applications that require multivariate statistical analyses. The aim of this review is to provide an overview of the new prospects for chiral CE method development applied for the enantiomeric purity control of pharmaceuticals using AQbD principles. The review also provides an overview of recent research (2012-2022) on the applicability of CE methods in chiral drug impurity profiling.
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