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Method Transfer Evaluation for Digital Derivative Spectrophotometry Through its Resolution Parameter Comparison of

Ana Homšek1, Bojan Marković2, Nataša Bogavac-Stanojević3

  • 1Department of Analytical Chemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.

Applied Spectroscopy
|March 14, 2020
PubMed
Summary
This summary is machine-generated.

Method transfer in derivative spectrophotometry requires program validation. Equivalence testing using the A/B ratio parameter confirmed successful method transfer between specific software programs, but highlighted discrepancies with others.

Keywords:
Digital derivative spectraEPEuropean Pharmacopoeiaamplitude A/B ratio–resolution parameterequivalence testsmethod transferprogram algorithms evaluation

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Area of Science:

  • Analytical Chemistry
  • Spectroscopy
  • Method Validation

Background:

  • Derivative spectrophotometry is crucial for spectral analysis.
  • Ensuring method transferability between different software and instruments is vital for reproducible results in analytical laboratories.

Purpose of the Study:

  • To assess the applicability of different software programs for method transfer in second-order derivative spectrophotometry.
  • To evaluate the reliability of the amplitude A/B ratio as a resolution parameter for program comparison.

Main Methods:

  • Digital second-order derivative spectra were calculated using software from GBC (Cintral, Spectral) and Thermo Scientific (VISIONPro).
  • The amplitude A/B ratio, a European Pharmacopoeia resolution parameter, was analyzed to compare spectral data.
  • Equivalence tests were performed to assess method transferability between programs and instruments.

Main Results:

  • The amplitude A/B ratio varied significantly across different software programs and instruments.
  • Method transfer was feasible between Spectral v.1.70 and VISIONPro (medium indirect, one-step Savitzky-Golay 7).
  • Data processed in Cintral v.2.6 showed non-comparable results, indicating limitations in method transfer.

Conclusions:

  • The amplitude A/B ratio serves as a reliable parameter for verifying program comparison and enabling method transfer.
  • Software algorithm accordance can be confirmed by achieving acceptable differences in resolution parameter values.
  • Careful software selection and validation are necessary for successful method transfer in derivative spectrophotometry.