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Chiral drugs: an industrial analytical perspective
T J Wozniak1, R J Bopp, E C Jensen
1Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, IN 46285.
Journal of Pharmaceutical and Biomedical Analysis
|January 1, 1991
Summary
Analytical chemists face challenges with chiral drug candidates, requiring enantioselective methods for stereochemical characterization. Proper method development and validation are crucial for accurate data in drug registration.
Area of Science:
- Pharmaceutical Analysis
- Medicinal Chemistry
- Analytical Chemistry
Background:
- Chiral drug candidates present unique analytical challenges in pharmaceutical development.
- Characterizing stereoisomeric issues is essential for analytical chemists.
- Chiral drugs require more analytical data than achiral counterparts.
Purpose of the Study:
- To discuss the development and validation of chiral analytical methods.
- To highlight the generation of analytical data for chiral drug registration.
- To address challenges in stereochemical characterization.
Main Methods:
- Enantioselective spectroscopic techniques
- Enantioselective chromatographic techniques
- Method development and validation
Main Results:
- Analytical data for stereoisomeric purity determination is critical.
- Awareness of development challenges aids in data presentation.
- Appropriate methodology ensures accurate stereochemical characterization.
Conclusions:
- Enantioselective methods are key for analyzing chiral drug candidates.
- Robust method validation is necessary for reliable stereochemical data.
- Accurate analytical data is vital for the successful registration of chiral drugs.