Strategies for capillary electrophoresis: Method development and validation for pharmaceutical and biological applications—Updated and completely revised edition

Author:

Krebs Finja1ORCID,Zagst Holger1,Stein Matthias1,Ratih Ratih2ORCID,Minkner Robert1ORCID,Olabi Mais1,Hartung Sophie1,Scheller Christin1,Lapizco‐Encinas Blanca H.3ORCID,Sänger‐van de Griend Cari45ORCID,García Carlos D.6ORCID,Wätzig Hermann1ORCID

Affiliation:

1. Institute of Medicinal and Pharmaceutical Chemistry Technische Universität Braunschweig Braunschweig Lower Saxony Germany

2. Department of Pharmaceutical Chemistry, Faculty of Pharmacy University of Surabaya Surabaya East Java Indonesia

3. Department of Biomedical Engineering, Kate Gleason College of Engineering Rochester Institute of Technology Rochester New York USA

4. Kantisto BV Baarn The Netherlands

5. Department of Medicinal Chemistry, Faculty of Pharmacy Uppsala Universitet Uppsala Sweden

6. Department of Chemistry Clemson University Clemson South Carolina USA

Abstract

AbstractThis review is in support of the development of selective, precise, fast, and validated capillary electrophoresis (CE) methods. It follows up a similar article from 1998, Wätzig H, Degenhardt M, Kunkel A. “Strategies for capillary electrophoresis: method development and validation for pharmaceutical and biological applications,” pointing out which fundamentals are still valid and at the same time showing the enormous achievements in the last 25 years. The structures of both reviews are widely similar, in order to facilitate their simultaneous use. Focusing on pharmaceutical and biological applications, the successful use of CE is now demonstrated by more than 600 carefully selected references. Many of those are recent reviews; therefore, a significant overview about the field is provided. There are extra sections about sample pretreatment related to CE and microchip CE, and a completely revised section about method development for protein analytes and biomolecules in general. The general strategies for method development are summed up with regard to selectivity, efficiency, precision, analysis time, limit of detection, sample pretreatment requirements, and validation.

Funder

National Science Foundation

Publisher

Wiley

Subject

Clinical Biochemistry,Biochemistry,Analytical Chemistry

Reference610 articles.

1. Strategies for capillary electrophoresis: Method development and validation for pharmaceutical and biological applications

2. ShapiroM.An FDA perspective on the implementation of state‐of‐the‐art analytical methods for therapeutic proteins.2018. Available from:https://www.casss.org/detail‐pages/resource/an‐fda‐perspective‐on‐the‐implementation‐of‐state‐of‐the‐art‐analytical‐methods‐for‐the‐development‐of‐therapeutic‐proteins

3. Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

4. Selectivity in analytical chemistry (IUPAC Recommendations 2001)

5. https://www.ema.europa.eu/en/documents/scientific‐guideline/ich‐q‐2‐r1‐validation‐analytical‐procedures‐text‐methodology‐step‐5_en.pdf

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