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Pharmaceutical quantification with univariate analysis using transmission Raman spectroscopy.

Rie Shimamura1, Tatsuo Koide2, Hiroshi Hisada1

  • 1a Department of Molecular Pharmaceutics , Meiji Pharmaceutical University , Kiyose , Japan.

Drug Development and Industrial Pharmacy
|May 21, 2019
PubMed
Summary

Transmission Raman spectroscopy with univariate analysis offers a suitable method for quantifying acetaminophen in large sample sizes for content uniformity testing. This technique showed good correlation with UV-vis methods, despite minor daily variations.

Keywords:
Raman spectroscopymultivariate analysisquantificationtransmissionunivariate analysis

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Area of Science:

  • Analytical Chemistry
  • Spectroscopy
  • Pharmaceutical Analysis

Background:

  • Raman spectroscopy is a valuable technique for chemical analysis.
  • Quantitative analysis of pharmaceutical formulations requires accurate and reliable methods.
  • Transmission Raman spectroscopy offers a non-destructive approach for analyzing solid dosage forms.

Purpose of the Study:

  • To evaluate the quantification performance of transmission Raman spectroscopy using univariate analysis.
  • To compare transmission Raman spectroscopy with other measurement modes and multivariate analysis.
  • To determine the suitability of transmission Raman spectroscopy for content uniformity testing.

Main Methods:

  • Preparation of model dosage forms containing acetaminophen and lactose monohydrate.
  • Acquisition of Raman spectra using transmission, backscattering, and wide area illumination modes.
  • Creation of calibration curves using peak heights and comparison with partial least squares (PLS) multivariate analysis.

Main Results:

  • Transmission Raman spectroscopy demonstrated the highest correlation with UV-vis methods for acetaminophen quantification.
  • Univariate analysis using transmission mode showed some daily variation.
  • PLS multivariate analysis provided better precision (lower RMSEP) than the peak height method.

Conclusions:

  • Univariate analysis with transmission Raman spectroscopy is a suitable quantitative method for content uniformity testing of large sample sizes.
  • While PLS offers higher precision, univariate analysis is sufficient given the typical criteria and ranges for content uniformity.
  • Transmission Raman spectroscopy provides a viable alternative for pharmaceutical quality control.