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Related Experiment Videos

Quantification of olanzapine polymorphs using powder X-ray diffraction technique.

Manisha Tiwari1, Garima Chawla, Arvind K Bansal

  • 1Department of Pharmaceutical Technology (Formulations), National Institute of Pharmaceutical Education and Research, SAS Nagar, Punjab, India.

Journal of Pharmaceutical and Biomedical Analysis
|October 13, 2006
PubMed
Summary

This study developed a powder X-ray diffraction (PXRD) method for quantifying olanzapine (OLZ) polymorphic forms. The optimized method accurately measures crystalline phases, addressing regulatory needs for drug substance characterization.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Analytical Chemistry

Background:

  • Accurate quantification of crystalline phases in drug materials is critical for regulatory compliance.
  • Polymorph characterization and control are essential for drug substances and products.
  • Powder X-ray diffraction (PXRD) is a key technique for analyzing crystalline materials.

Purpose of the Study:

  • To develop and validate a quantitative PXRD method for determining polymorphic forms of olanzapine (OLZ).
  • To address and minimize the impact of preferred orientation, a common source of error in PXRD analysis.
  • To establish a reproducible and precise assay for olanzapine polymorph quantification.

Main Methods:

  • Optimization of PXRD parameters including step size and step time to achieve good peak resolution.

Related Experiment Videos

  • Analysis of pure polymorphic forms (I and II) of olanzapine to assess preferred orientation effects.
  • Development of a calibration curve using a characteristic peak of form I for quantitative analysis.

    • Main Results:

    • A reduced preferred orientation effect was observed using sieve fraction BSS # 120/240 for form I.
    • Optimized PXRD scan parameters (0.05° step size, 5s step time) allowed identification of form I in form II within 62 minutes.
    • The developed PXRD assay demonstrated high reproducibility, precision, and accuracy, with an R² value of 0.9999.

    Conclusions:

    • A robust and validated PXRD quantification method for olanzapine polymorphic forms has been successfully developed.
    • The method effectively minimizes preferred orientation errors, enhancing analytical accuracy.
    • This quantitative PXRD assay meets regulatory requirements for polymorph characterization in pharmaceutical development.