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Related Experiment Videos

Active drug substance impurity profiling part I. LC/UV diode array spectral matching

E C Nicolas1, T H Scholz

  • 1The DuPont Merck Pharmaceutical Company, Deepwater, NJ 08023, USA.

Journal of Pharmaceutical and Biomedical Analysis
|April 16, 1998
PubMed
Summary

UV spectral matching effectively monitors drug impurities, even minor ones below 0.1%, by comparing UV spectra without isolation. This technique enhances impurity profiling for drug development, ensuring quality control.

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Area of Science:

  • Pharmaceutical Analysis
  • Analytical Chemistry
  • Drug Development

Background:

  • High-Performance Liquid Chromatography (HPLC) is standard for drug impurity monitoring.
  • Variable HPLC retention times create uncertainty in identifying new impurities.
  • Lack of standards for minor impurities (<0.1%) necessitates alternative characterization methods.

Purpose of the Study:

  • To assess UV diode array spectral matching for on-line characterization of drug impurities.
  • To evaluate the sensitivity and selectivity of UV spectral matching for impurity profiling.
  • To apply UV spectral matching to monitor impurities in the anti-cancer drug DuP 941.

Main Methods:

  • Generated an ultraviolet spectral data library for known DuP 941 impurities.

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  • Examined impurities in subsequent DuP 941 lots using LC/UV spectral matching.
  • Compared spectral characteristics against the established library.

    • Main Results:

    • LC/UV spectral matching proved powerful for monitoring DuP 941 impurities.
    • The technique successfully identified impurities well below 0.1% by area.
    • Detector sensitivity, lamp intensity, and spectral similarity of impurities influenced utility.

    Conclusions:

    • UV spectral matching is a valuable tool for sensitive and selective drug impurity monitoring.
    • This method aids in characterizing unknown impurities without isolation.
    • Optimizing detector parameters is crucial for effective spectral matching in drug analysis.