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Raman Spectroscopy Instrumentation: Overview01:26

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A conventional Raman spectrophotometer includes a laser source, a sample holding system, a wavelength selector, and a detector.
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A Novel Technique for Raman Analysis of Highly Radioactive Samples Using Any Standard Micro-Raman Spectrometer
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Quantitative determinations using portable Raman spectroscopy.

Chelliah V Navin1, Chaitanya Tondepu1, Roxana Toth1

  • 1Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, 645 S. Newstead Ave., Saint Louis, MO, 63110, United States.

Journal of Pharmaceutical and Biomedical Analysis
|January 13, 2017
PubMed
Summary
This summary is machine-generated.

Portable Raman spectrometers accurately measure drug release and potency in ciprofloxacin tablets. This technology shows promise for pharmaceutical quality control and surveillance.

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Spectroscopy

Background:

  • Accurate determination of drug release and potency is crucial for pharmaceutical quality control.
  • Portable analytical instruments offer potential for in-field and at-line analysis.
  • Ciprofloxacin hydrochloride is a widely used antibiotic requiring stringent quality assessment.

Purpose of the Study:

  • To develop and validate chemometric models using a portable Raman spectrometer.
  • To quantitatively determine drug release (dissolution) and potency (assay) of ciprofloxacin HCl tablets.
  • To compare the performance of portable Raman spectroscopy with traditional methods like dissolution and chromatography.

Main Methods:

  • Utilized a portable Raman spectrometer to analyze 500mg ciprofloxacin HCl tablets.
  • Developed chemometric models for predicting drug release and potency.
  • Performed parallel dissolution testing (UV spectroscopy) and chromatographic analysis for comparison.
  • Assessed model performance against established pharmaceutical specifications.

Main Results:

  • Raman-based drug release models accurately reproduced dissolution profiles obtained via UV spectroscopy.
  • Potency (assay) results from portable Raman were comparable to chromatographic methods (99.4±5.1% vs. 99.2±1.2% label claim).
  • All tested batches met dissolution specifications, and both methods confirmed tablet potency.

Conclusions:

  • Portable Raman spectrometers are capable of quantitative analysis for critical drug attributes in finished pharmaceutical products.
  • The technology demonstrates potential for applications in process analytical technology (PAT) and rapid pharmaceutical surveillance.
  • Portable Raman spectroscopy offers a viable, non-destructive alternative for quality control in the pharmaceutical industry.