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API Content and Blend Uniformity Using Quantum Cascade Laser Spectroscopy Coupled with Multivariate Analysis.

Vladimir Villanueva-López1, Leonardo C Pacheco-Londoño1,2,3, Reynaldo Villarreal-González3

  • 1ALERT DHS Center of Excellence for Explosives Research, Department of Chemistry, University of Puerto Rico, Mayagüez, PR 00681, USA.

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Summary
This summary is machine-generated.

Mid-infrared quantum cascade laser (QCL) spectroscopy accurately quantifies ibuprofen in pharmaceutical blends and tablets. This vibrational spectroscopy method, combined with multivariate analysis, ensures drug quality control during manufacturing.

Keywords:
PATblend uniformitycontent uniformityinfrared spectroscopyquantum cascade laser

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Spectroscopy

Background:

  • Process Analytical Technology (PAT) aims to enhance pharmaceutical process understanding and control.
  • Quantifying active pharmaceutical ingredients (APIs) is crucial for drug product quality.
  • Vibrational spectroscopy offers non-destructive, in-line analysis without sample preparation.

Purpose of the Study:

  • To develop and validate a mid-infrared (MIR) quantum cascade laser (QCL) spectroscopy method for quantifying ibuprofen.
  • To assess the accuracy and robustness of the method for API content and blend uniformity in powder blends and tablets.

Main Methods:

  • Utilized MIR QCL spectroscopy in the 990-1600 cm-1 range.
  • Prepared fourteen powder blends with API concentrations from 0.0% to 21.0% (w/w).
  • Developed Partial Least Squares (PLS) models to correlate spectral data with API concentrations.

Main Results:

  • PLS models demonstrated strong correlation (R2) between spectral intensities and ibuprofen concentrations.
  • The QCL-based method proved accurate and robust for quantifying API in both powder blends and tablets.
  • Evaluated model performance using standard figures of merit like RMSEP and RSE.

Conclusions:

  • MIR QCL spectroscopy, coupled with multivariate analysis, is a reliable PAT tool for pharmaceutical quality control.
  • The developed method effectively analyzes content and blend uniformity of pharmaceutical compounds.
  • This approach supports real-time monitoring and enhances manufacturing process understanding.