Classification of the Ibuprofen Active Pharmaceutical Ingredients by chemical patterns combining HPLC, 1H-NMR spectroscopy and Chemometrics: Traceability of legal medicines.
Authors
Mariangela Raimondo, Anna Borioni, Monica Bartolomei, Antonina Mosca, Gianluca Gostoli
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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