Nondestructive Control of Macrolides in Tableted Pharmaceuticals Using Near-IR Fourier-Transform Spectrometry and Digital Colorimetry

A method is proposed for the nondestructive control of azithromycin and clarithromycin active substances in tableted pharmaceuticals without opening blister packs by measuring the intensity of the diffuse reflection of IR radiation. Two methods are used: near-IR Fourier-transform spectrometry and colorimetry using a smartphone and a 3D-printed device. The data array (IR diffuse-reflection spectra and digital values of colorimetric channels) were processed by principal component analysis, hierarchical cluster analysis, and partial least squares regression using the TQ Analyst, PhotoMetrix PRO® software. The use of chemometric algorithms for the determination of the concentration of active substances and the identification of the producer of the studied pharmaceuticals was considered. Methods of IR spectrometry and colorimetry have shown equally precise results in the identification of the producer of pharmaceuticals and the determination of the concentration of active substances in tablets without opening blister packs.