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, 1H-NMR 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.