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Recognizing paracetamol formulations with the same synthesis pathway based on their trace-enriched chromatographic
M Dumarey1, A M van Nederkassel, I Stanimirova
1Vrije Universiteit Brussel, Department of Analytical Chemistry and Pharmaceutical Technology, Laarbeeklaan 103, 1090 Brussels, Belgium.
Analytica Chimica Acta
|November 21, 2009
Summary
This study demonstrates that analyzing impurity profiles using high-performance liquid chromatography (HPLC) and chemometrics can distinguish paracetamol synthesized via different pathways, aiding in the detection of fraudulent drug manufacturing.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Sciences
- Chemometrics
Background:
- Drug development is costly, leading to patenting of molecules and synthesis pathways.
- Detecting fraudulently synthesized drugs is crucial for maintaining pharmaceutical integrity.
- Impurity profiles can vary significantly based on the synthesis route.
Purpose of the Study:
- To differentiate paracetamol drug formulations based on their synthesis pathways.
- To demonstrate the feasibility of identifying fraudulently synthesized paracetamol.
- To explore the use of chemometric analysis for impurity profiling.
Main Methods:
- Synthesis of paracetamol samples via four distinct pathways.
- Analysis using trace-enrichment high-performance liquid chromatography (HPLC).
- Chemometric treatment of chromatographic data including Principal Component Analysis (PCA), Projection Pursuit (PP), Hierarchical Clustering, and Auto-Associative Multivariate Regression Trees (AAMRT).
Main Results:
- Projection Pursuit (PP) successfully revealed four clusters, classifying most samples correctly by synthesis pathway.
- Hierarchical clustering and AAMRT also distinguished between the four synthesis pathways.
- Auto-Associative Multivariate Regression Trees (AAMRT) identified specific impurities responsible for pathway differentiation.
Conclusions:
- Chemometric analysis of HPLC impurity profiles is effective in distinguishing paracetamol synthesized through different routes.
- This method holds potential for detecting fraudulent synthesis of pharmaceutical products.
- AAMRT offers additional value by pinpointing critical differentiating impurities.
