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Automatization for development of HPLC methods.

M Pfeffer1, H Windt

  • 1Research Laboratories Schering AG, 13342 Berlin, Germany.

Fresenius' Journal of Analytical Chemistry
|February 24, 2001
PubMed
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Automated screening of 12 High-Performance Liquid Chromatography (HPLC) columns and mobile phase optimization significantly reduced method development time for pharmaceutical quality control. This approach saves over a third of manpower, enabling rapid impurity profiling.

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Science

Background:

  • High-Performance Liquid Chromatography (HPLC) is crucial for in-process analytics in pharmaceutical synthesis.
  • Developing robust HPLC methods with optimal selectivity, low detection limits, and short run times is essential but time-consuming.

Purpose of the Study:

  • To significantly shorten the HPLC method development process for pharmaceutical intermediates and drug substances.
  • To automate the screening of stationary phases and optimize mobile phase composition.

Main Methods:

  • Automated screening of 12 HPLC columns using a column switching module.
  • Optimization of mobile phase and temperature using Drylab software based on automatically evaluated chromatograms.
  • Application of the column switching module for over 36 substances, including steroidal intermediates.

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Main Results:

  • Resolution, peak shape, and peak count were key criteria for selecting the optimal stationary phase.
  • Rapid identification of the best eluent composition was achieved based on the selected "best" column.
  • Significant savings in manpower (over one-third) and overnight impurity profiling were realized.

Conclusions:

  • Automated HPLC method development streamlines quality control for pharmaceutical synthesis.
  • The described approach yields robust methods with high selectivity and minimized elution times.
  • This strategy enhances efficiency and reduces resource allocation in pharmaceutical analysis.