Classification of the Ibuprofen Active Pharmaceutical Ingredients by chemical patterns combining HPLC, 1H-NMR spectroscopy and Chemometrics: Traceability of legal medicines.

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Abstract

Introduction. Ibuprofen is one of the widespread used non-steroidal anti-inflammatory
drugs. Ibuprofen active ingredient is manufactured in many sites located all around the
world. The aim of this paper was to classify the geographical source of ibuprofen active
pharmaceutical ingredients (APIs) from the legal market, based on chemical characteristics
and its impurity pattern and to define a geographical fingerprint.
Methods. To classify ibuprofen in different geographical groups, the chemometrics by
principal component analysis (PCA) and Cluster analysis was applied to HPLC, 1HNMR
data of twenty-four samples of APIs from approved manufacturers located in different
European and Asian countries.
Results. The PCA showed clearly two different geographical groups, based on particular
patterns of European or Indian samples; the cluster analysis showed the similarity of
group.
Conclusion. The chemometric analysis is an important tool for tracking the geographical origin of APIs. This could be useful to supplement the quality control ensuring safety of the medicinal products in legal market and dealing with the evolving changes of the illegal market.

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Authors

Mariangela Raimondo - Istituto Superiore di Sanità, National Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit https://orcid.org/0000-0002-6766-7948

Anna Borioni - Istituto Superiore di Sanità, National Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit

Monica Bartolomei - Istituto Superiore di Sanità, National Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit

Antonina Mosca - Istituto Superiore di Sanità, National Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit

Gianluca Gostoli - Agenzia Italiana del Farmaco, AIFA

How to Cite
Raimondo, M., Borioni, A., Bartolomei, M., Mosca, A., & Gostoli, G. (2020). Classification of the Ibuprofen Active Pharmaceutical Ingredients by chemical patterns combining HPLC, 1H-NMR spectroscopy and Chemometrics: Traceability of legal medicines. Annali dell’Istituto Superiore Di Sanità, 56(4), 403-408. Retrieved from https://annali.iss.it/index.php/anna/article/view/1053
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