New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods
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 va...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-10-01
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| Series: | Molecules |
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| Online Access: | https://www.mdpi.com/1420-3049/27/20/7058 |
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| author | Serena Orlandini Gabriel Hancu Zoltán-István Szabó Adriana Modroiu Lajos-Attila Papp Roberto Gotti Sandra Furlanetto |
| author_facet | Serena Orlandini Gabriel Hancu Zoltán-István Szabó Adriana Modroiu Lajos-Attila Papp Roberto Gotti Sandra Furlanetto |
| author_sort | Serena Orlandini |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T19:41:21Z |
| format | Article |
| id | doaj.art-6059ff7090fa4de792a1f6d4c42b50e3 |
| institution | Directory Open Access Journal |
| issn | 1420-3049 |
| language | English |
| last_indexed | 2024-03-09T19:41:21Z |
| publishDate | 2022-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Molecules |
| spelling | doaj.art-6059ff7090fa4de792a1f6d4c42b50e32023-11-24T01:36:34ZengMDPI AGMolecules1420-30492022-10-012720705810.3390/molecules27207058New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis MethodsSerena Orlandini0Gabriel Hancu1Zoltán-István Szabó2Adriana Modroiu3Lajos-Attila Papp4Roberto Gotti5Sandra Furlanetto6Department of Chemistry “U. Schiff”, University of Florence, 50019 Florence, ItalyDepartment of Pharmaceutical and Therapeutic Chemistry, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology “George Emil Palade” of Târgu Mureș, 540139 Târgu Mureș, RomaniaDepartment of Pharmaceutical Industry and Management, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology “George Emil Palade” of Târgu Mureș, 540139 Târgu Mureș, RomaniaDepartment of Pharmaceutical and Therapeutic Chemistry, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology “George Emil Palade” of Târgu Mureș, 540139 Târgu Mureș, RomaniaDepartment of Pharmaceutical and Therapeutic Chemistry, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology “George Emil Palade” of Târgu Mureș, 540139 Târgu Mureș, RomaniaDepartment of Pharmacy and Biotechnology, University of Bologna, 40126 Bologna, ItalyDepartment of Chemistry “U. Schiff”, University of Florence, 50019 Florence, ItalyCapillary 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.https://www.mdpi.com/1420-3049/27/20/7058chiral separationcapillary electrophoresisenantiomeric purityexperimental designAnalytical Quality by DesignICH guidelines |
| spellingShingle | Serena Orlandini Gabriel Hancu Zoltán-István Szabó Adriana Modroiu Lajos-Attila Papp Roberto Gotti Sandra Furlanetto New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods Molecules chiral separation capillary electrophoresis enantiomeric purity experimental design Analytical Quality by Design ICH guidelines |
| title | New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods |
| title_full | New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods |
| title_fullStr | New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods |
| title_full_unstemmed | New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods |
| title_short | New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods |
| title_sort | new trends in the quality control of enantiomeric drugs quality by design compliant development of chiral capillary electrophoresis methods |
| topic | chiral separation capillary electrophoresis enantiomeric purity experimental design Analytical Quality by Design ICH guidelines |
| url | https://www.mdpi.com/1420-3049/27/20/7058 |
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