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Related Concept Videos

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Rapid quantification of low level polymorph content in a solid dose form using transmission Raman spectroscopy.

Julia A Griffen1, Andrew W Owen1, Jonathan Burley2

  • 1Cobalt Light Systems Ltd., Milton Park, Abingdon, OX14 4SD, UK.

Journal of Pharmaceutical and Biomedical Analysis
|May 25, 2016
PubMed
Summary

Transmission Raman spectroscopy (TRS) non-destructively quantifies low levels of active pharmaceutical ingredient polymorphic forms in formulations. This method enables rapid, single-measurement analysis of all tablet components and polymorphic transformations.

Keywords:
ChemometricsDoEHigh throughput screeningPolymoprhStability analysisTransmission raman

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Area of Science:

  • Pharmaceutical Analysis
  • Spectroscopy
  • Solid-State Chemistry

Background:

  • Accurate quantification of active pharmaceutical ingredient (API) polymorphic forms is crucial for drug efficacy and stability.
  • Non-invasive and non-destructive analytical techniques are highly desirable for pharmaceutical quality control.
  • Current methods for polymorphic form analysis can be time-consuming or destructive.

Purpose of the Study:

  • To demonstrate the feasibility of transmission Raman spectroscopy (TRS) for quantifying low levels of API polymorphic forms in pharmaceutical formulations.
  • To assess the capability of TRS for simultaneous quantification of all tablet constituents.
  • To evaluate the performance of TRS in analyzing stability samples and its speed enhancement using a beam enhancer.

Main Methods:

  • Transmission Raman spectroscopy (TRS) was employed for quantitative analysis.
  • Partial least squares (PLS) calibration models were developed and validated.
  • A beam enhancer device was utilized to improve laser coupling and measurement speed.

Main Results:

  • TRS accurately quantified low levels (0.62-1.32% w/w) of polymorphic forms with low prediction errors (RMSEP 0.03-0.05% w/w) and a limit of detection of 0.1-0.2% w/w.
  • Simultaneous quantification of all tablet constituents was achieved in a single measurement.
  • Stability studies revealed polymorphic transformations without changes in excipient levels.
  • The beam enhancer enabled a 60-fold increase in measurement speed (0.2s) with comparable performance.

Conclusions:

  • TRS is a viable technique for non-invasive, non-destructive quantification of API polymorphic forms in pharmaceutical formulations.
  • TRS offers a rapid, single-measurement solution for comprehensive tablet analysis.
  • The use of a beam enhancer significantly accelerates TRS analysis without compromising accuracy, making it suitable for high-throughput applications.