Investigating the Quality of Antimalarial Generic Medicines Using Portable Near-Infrared Spectroscopy

摘要

The development of non-destructive and rapid methods of authentication is critical in an era of expanding counterfeit and poor-quality medicines production. This development is critical in cases such as antimalarial medicines'that represent one of the main classes of medicines posing a threat to the public. Amongst the promising non-destructive techniques of identification, portable near-infrared spectroscopy stands out. This is attributed to its mobility and rapid analysis as well as its capability of analyzing both the chemical and physical properties of the sample. Therefore, the present work examines the feasibility of combining near-infrared spectroscopy with multivariate data analysis algorithms for the authentication of antimalarial medicines obtained from different countries. Medicines and their corresponding constituents were measured using a portable near-infrared spectrometer equipped with a near-infrared reflectance module. Tablets were measured as received from both sides and powders were measured through transparent glass vials. The spectra of powders were collected over the wavenumber range of 4000 - 400 cm1 and exported to Matlab R2019a where multivariate classification algorithms were applied. The results showed that the medicines showed spectral features corresponding to their constituents (whether active pharmaceutical ingredient and excipient(s)) depending on the amount these constituents were present in the medicines. This was useful in case of undeclared excipients as is the case in some generics. Applying multivariate data analysis algorithms to the near-infrared spectra goes beyond confirming the presence/absence of the constituents into locating the manufacturing sources. However, this was not possible where constituents were present in low amounts within a medicine. In summary, the results demonstrated that portable near infrared spectroscopy was useful in locating manufacturing sources of generic antimalarials and identifying unknown constituents in medicines that are present in high amounts. However, where multiple constituents were present in low concentrations a more quantitative approach is needed.