Неразрушающий контроль нестероидных противовоспалительных средств методом ИК-спектроскопии в ближней области

Abstract

The use of near-infrared spectroscopy for quality control of nonsteroidal anti-inflammatory drugs (NSAIDs) in blister packs is demonstrated. NSAIDs with the active ingredients ibuprofen, diclofenac, naproxen, etoricoxib, acetylsalicylic acid and meloxicam have been studied. IR spectra have been recorded using a Frontier FTIR spectrometer with a NIRA attachment, used to collect diffuse reflectance spectra of solids. Processing and visualization of the study results has been carried out using chemometric algorithms – principal component analysis (PCA), hierarchical cluster analysis (HCA) and partial least squares regression (PLS). It is shown that using these algorithms it is possible to identify drugs by their manufacturer and determine the concentration of active substances. In the PCA method, the points corresponding to the samples of the analyzed tablets are located in separate quadrants depending on their manufacturer. The use of hierarchical cluster analysis (HCA) made it possible not only to differentiate the analyzed tablets by manufacturer, but also to determine the content of the active substance in them. “Measured-predicted” calibration models have been constructed, the values of the root mean square residual of calibration (RMSEC) did not exceed 6.28 mg. The relative discrepancies between the values obtained during the analysis and those assigned correspond to the permissible deviations established by order of the Ministry of Health of the Russian Federation dated October 26, 2015 no. 751n. The duration of the analysis was 7–10 min.