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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products

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Rietveld refinement in the routine quantitative analysis of famotidine polymorphs.

Zoltán Német¹, István Sajó, Adám Demeter

¹Drug Polymorphism Research Division, Gedeon Richter Plc., P.O. Box 27, H-1475 Budapest, Hungary. z.nemet@richter.hu

Journal of Pharmaceutical and Biomedical Analysis

|October 13, 2009

Summary

A new X-ray powder diffraction method accurately quantifies famotidine polymorphic forms. This technique offers improved reliability over Raman spectroscopy for pharmaceutical analysis.

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Area of Science:

Analytical Chemistry
Materials Science
Pharmaceutical Analysis

Background:

Famotidine exists in multiple polymorphic forms, impacting drug efficacy and stability.
Accurate quantification of these forms is crucial for pharmaceutical quality control.
Existing methods like Raman spectroscopy have limitations in certain applications.

Purpose of the Study:

To develop and validate a precise X-ray powder diffraction (XRPD) method for quantitative determination of famotidine polymorphic forms.
To compare the performance of the developed XRPD method with the established Raman spectroscopy method.
To optimize XRPD parameters for routine, high-throughput analysis.

Main Methods:

Development of an X-ray powder diffraction method utilizing focused beam transmission geometry.
Implementation of a straightforward transmission foil sample preparation technique.
Application of Rietveld refinement for quantitative analysis of famotidine polymorphic forms in binary mixtures.

Main Results:

The developed XRPD method demonstrated high accuracy, precision, and reliability for quantitative determination of famotidine polymorphic forms.
The XRPD method slightly outperformed the previously established Raman method in terms of accuracy and reliability.
Focused beam transmission geometry effectively minimized preferred orientation effects.
Transmission foil sample preparation enabled efficient, high-throughput measurements.

Conclusions:

The optimized XRPD method provides a robust and reliable approach for quantifying famotidine polymorphic forms.
This method offers advantages over existing techniques, particularly in handling preferred orientation and enabling high-throughput analysis.
The developed XRPD method is suitable for routine application in pharmaceutical quality control.