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Related Experiment Videos

Quantitative analysis of the active tablet ingredient by powder X-ray diffractometry.

R Suryanarayanan1, C S Herman

  • 1Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis 55455.

Pharmaceutical Research
|March 1, 1991
PubMed
Summary

A new powder X-ray diffraction method allows quantitative analysis of active pharmaceutical ingredients in intact tablets. This technique shows promise for accurate drug content determination, with errors under 10% for lithium carbonate and carbamazepine at higher concentrations.

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Area of Science:

  • Pharmaceutical analysis
  • Materials science
  • Analytical chemistry

Background:

  • Accurate quantification of active pharmaceutical ingredients (APIs) in solid dosage forms is crucial for quality control.
  • Traditional methods for API analysis may require tablet disintegration, potentially altering the sample matrix.
  • Powder X-ray diffraction (PXRD) offers a non-destructive analytical approach for solid-state characterization.

Purpose of the Study:

  • To develop and validate a powder X-ray diffraction (PXRD) technique for the quantitative analysis of active ingredients within intact tablets.
  • To assess the accuracy and applicability of the PXRD method using model drugs like lithium carbonate (LC) and carbamazepine (CBZ).

Main Methods:

  • Development of a PXRD method utilizing integrated intensities of diffraction lines for quantitative analysis.

Related Experiment Videos

  • Preparation of binary mixtures of model drugs (LC, CBZ) with excipients (microcrystalline cellulose, starch) compressed into tablets.
  • Calculation of the ratio of integrated intensities in mixtures versus pure drug tablets as a function of drug weight fraction.

    • Main Results:

    • The PXRD method demonstrated quantitative analysis capabilities for APIs in intact tablets.
    • Relative error for lithium carbonate determination was less than 12%.
    • For carbamazepine, a relative error of less than 10% was achieved when the drug's weight fraction was 0.4 or higher, regardless of the excipient (microcrystalline cellulose or starch).

    Conclusions:

    • Powder X-ray diffraction is a viable technique for the non-destructive quantitative analysis of APIs in intact pharmaceutical tablets.
    • The method's accuracy is dependent on the drug's concentration, showing higher precision at higher weight fractions.
    • This PXRD approach offers a valuable tool for pharmaceutical quality control and formulation analysis.