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Related Experiment Videos

Quantitative analysis of mannitol polymorphs. FT-Raman spectroscopy.

Sarra N Campbell Roberts1, Adrian C Williams, Ian M Grimsey

  • 1Drug Delivery Group, School of Pharmacy, University of Bradford, West Yorkshire Bradford, UK.

Journal of Pharmaceutical and Biomedical Analysis
|June 7, 2002
PubMed
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This study introduces a non-destructive FT-Raman spectroscopy method to quantify beta-mannitol in pharmaceutical products. The technique accurately measures down to 2% beta-mannitol, even with common contaminants like delta-mannitol.

Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Spectroscopy

Background:

  • Mannitol is a key pharmaceutical excipient, primarily used as the beta polymorph.
  • Alpha and delta mannitol polymorphs are common contaminants, potentially affecting drug product quality.
  • Accurate quantification of mannitol polymorphs is crucial for pharmaceutical formulation and quality control.

Purpose of the Study:

  • To develop and validate a quantitative method for determining beta-mannitol concentration in binary mixtures with delta-mannitol.
  • To explore the utility of FT-Raman spectroscopy for rapid and non-destructive analysis of mannitol polymorphic mixtures.
  • To identify and mitigate sources of error in FT-Raman spectroscopic quantification of mannitol.

Main Methods:

  • Preparation of binary mixtures of beta and delta mannitol at known concentrations.

Related Experiment Videos

  • Utilizing FT-Raman spectroscopy to acquire spectra of the mixtures.
  • Selecting characteristic spectral regions and calculating peak intensity ratios (beta/delta).
  • Establishing a correlation curve and validating it with independent samples.
  • Investigating the impact of sample particle size and mixing homogeneity on measurement accuracy.

    • Main Results:

    • A robust correlation between FT-Raman spectral peak ratios and beta-mannitol concentration was established.
    • The method demonstrated the ability to quantify beta-mannitol levels as low as 2% non-destructively.
    • Sample inhomogeneity due to particle size was identified as a major source of variability.
    • Reducing and controlling particle size significantly decreased measurement errors.
    • FT-Raman spectroscopy proved to be a rapid and accurate tool for quantifying polymorphic mixtures.

    Conclusions:

    • FT-Raman spectroscopy offers a viable, non-destructive method for the accurate quantification of beta-mannitol in the presence of delta-mannitol.
    • Controlling particle size is essential for minimizing errors and ensuring reliable results in FT-Raman spectroscopic analysis of mannitol polymorphs.
    • This technique has significant potential for quality control and process monitoring in pharmaceutical manufacturing.