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Quantification of active ingredients in suppositories by FT-Raman spectroscopy
Roman Szostak1, Sylwester Mazurek
1Department of Chemistry, University of Wrocław, Poland. roman.szostak@chem.uni.wroc.pl
Drug Testing and Analysis
|April 18, 2012
Summary
This study presents a fast and reliable method using FT-Raman spectroscopy and partial least squares (PLS) to quantify acetaminophen (AAP) and diclofenac sodium (DS) in suppositories, achieving high accuracy.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Quantitative determination of active pharmaceutical ingredients (APIs) in suppositories is crucial for quality control.
- Existing methods may be time-consuming or require complex sample preparation.
Purpose of the Study:
- To develop and validate an efficient quantitative method for acetaminophen (AAP) and diclofenac sodium (DS) in suppositories.
- To utilize FT-Raman spectroscopy combined with partial least squares (PLS) for rapid analysis.
Main Methods:
- Quantitative analysis of AAP and DS using FT-Raman spectra.
- Partial Least Squares (PLS) regression modeling for spectral data treatment.
- Validation using Relative Standard Error of Prediction (RSEP) and recovery studies.
Main Results:
- Accurate quantification of AAP and DS in commercial suppositories with low RSEP values (1.6-2.8%).
- High correlation between predicted and declared concentrations, with recoveries of 99.4-100.2% for AAP and 99.6% for DS.
- Successful analysis of multiple commercial preparations with varying API concentrations.
Conclusions:
- The developed FT-Raman-PLS method is a fast, economic, and reliable approach for API quantification in suppositories.
- This technique offers a viable alternative for routine pharmaceutical quality control.
- The method demonstrates excellent accuracy and precision for both AAP and DS.
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