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

O. Ye Rodionova, A. V. Titova, F. Y. Godin, K. S. Balyklova, A. L. Pomerantsev, D. N. Rutledge

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Article number114917
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume219
DOIs
Publication statusPublished - 20 Sep 2022

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