Monitoring of the natural aging of Diclofenac tablets, NIR and MIR-ATR spectroscopy coupled with chemometrics data analysis

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 219; p. 114917
• Main Authors: Rodionova, O.Ye, Titova, A.V., Godin, F.Y., Balyklova, K.S., Pomerantsev, A.L., Rutledge, D.N.
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 20.09.2022
• Subjects: DD-SIMCA; Diclofenac sodium; Independent Components Analysis; Intact tablets; Long-term natural aging; Near InfraRed and Mid InfraRed-Attenuated Total Reflection spectroscopy; Diclofenac sodium; Near InfraRed and Mid InfraRed-Attenuated Total Reflection spectroscopy; Intact tablets; DD-SIMCA; Independent Components Analysis; Long-term natural aging
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2022.114917

This study presents the analysis of the natural long-term aging of both the intact tablets and the active pharmaceutical ingredient. No forced aging conditions were applied to the samples. It is shown that the near infrared spectroscopy of the intact tablets packed in plastic blisters, supported by chemometrics, is a reliable method for detection of even slight deviations of the medicine from its regular state. Independent components analysis helps to extract source signals from spectra of the composite object “a coated tablet sealed in polyvinylchloride blister". Further analysis of the near infrared and attenuated total reflectance infrared spectra of the pure substance confirmed that the aging process detected by the analysis of the intact tablets is directly related to the degradation of the active pharmaceutical ingredient. [Display omitted] •Long-term natural aging of tablets and active pharmaceutical substance are analyzed.•Non-invasive NIR spectrometry coupled with SIMCA reveals degradation of tablets.•ICA helps to elucidate spectra of potential degradation products.•Degradation of pharmaceutical substance is confirmed by NIR and MIR-ATR analysis.