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Fast method development and rapid analysis using a screening approach for enantiomeric separations in capillary
M Ilias Jimidar1, Willy Van Ael, Rekha Shah
1Global Analytical Development, Johnson & Johnson Pharmaceutical Research & Development, A Div. of Janssen Pharmaceutica N.V., Beerse, Belgium. ijimidar@prdbe.jnj.com
Journal of Capillary Electrophoresis and Microchip Technology
|September 17, 2004
Summary
A new screening method speeds up enantioselective capillary electrophoresis (CE) method development for chiral drug purity analysis. This approach rapidly identifies initial enantiomeric separations, reducing development time and costs.
Area of Science:
- Analytical Chemistry
- Separation Science
- Pharmaceutical Analysis
Background:
- Enantioselective capillary electrophoresis (CE) is crucial for determining chiral purity in pharmaceuticals.
- Traditional method development for enantioselective CE can be time-consuming and iterative.
Purpose of the Study:
- To develop a systemized screening approach to accelerate enantioselective CE method development.
- To enable rapid characterization of chiral purity for pharmaceutical compounds.
Main Methods:
- Utilized a screening strategy combining multiple chiral selectors in mixtures at various buffer pH values.
- Applied dedicated, efficient screening methods tailored for basic, neutral, and acidic compounds.
- Employed inexpensive, bare silica capillaries and common buffer systems with cyclodextrins.
Main Results:
- Achieved rapid enantiomeric separation for tested compounds, significantly reducing method development time (approx. 5.3 hours per compound).
- Demonstrated broad applicability to various low-molecular-weight compounds.
- The method proved to be simple, robust, reproducible, and cost-effective.
Conclusions:
- The proposed screening approach substantially decreases enantioselective CE method development cycle times.
- This systemized strategy offers a high-success-rate solution for early-stage pharmaceutical development and chiral purity assessment.