Near-Infrared Spectroscopy in the Analysis of Tablets EVALUATED

Near-infrared spectroscopy (NIRS) is a fast, low-cost, easy-to-use, non-destructive, reliable and versatile analytical method that provides chemical and physical information of virtually any matrix. In combination with chemometrics, it becomes a powerful tool for quality assurance and control in the pharmaceutical industry. Indeed, NIRS is suitable for analysis of solid pharmaceutical forms. Moreover, NIRS can be implemented during pharmaceutical development, in production for process monitoring or in quality control laboratories. This project focuses on an important pharmaceutical NIR application, i.e. the direct analysis of intact solid dosage forms, namely tablets. Two case studies about the use of the application of near-infrared spectroscopy in the analysis of tablets are presented: detection of suspected counterfeit Concor® 5 tablets and transferability of a classification model between two laboratory near-infrared spectrometers for the identification of Thyrozol film-coated tablets. The results from the first project demonstrated that it is possible to use NIRS as a helpful fast screening method to distinguish genuine Concor® tablets from counterfeit drugs. On the second project, the spectral library was tested on two instrumental setups and found to be directly transferable between the two different FT-spectrometers without using any pre-treatment technique. However, considering the whole spectral region, the spectral response of the NIR instruments is significantly different. In this situation, the chemometric approach was found to perform well in the pre-processing of data to permit the spectral data transfer from one instrument to be used on another instrument.
Chemometrics, Counterfeiting, Instrument Standardisation, Near-Infrared Spectroscopy, Tablets.

Maio 8, 2008, 10:0

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Dirk Lochmann

Merck KgaA



José Monteiro Cardoso de Menezes

Departamento de Engenharia Química e Biológica (DEQB)

Professor Auxiliar