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

doi:10.1016/j.jpba.2022.114917

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

J Pharm Biomed Anal. 2022 Sep 20:219:114917. doi: 10.1016/j.jpba.2022.114917. Epub 2022 Jun 27.

Authors

O Ye Rodionova¹, A V Titova², F Y Godin², K S Balyklova³, A L Pomerantsev⁴, D N Rutledge⁵

Affiliations

¹ Information and Methodological Center for Expertise, Stocktaking and Analysis of Circulation of Medical Products, Roszdravnadzor, Slavyanskay sq., 4-1, 109074 Moscow, Russia; Semenov Federal Research Center for Chemical Physics RAS, Kosygin 4, 119991 Moscow, Russia.
² Information and Methodological Center for Expertise, Stocktaking and Analysis of Circulation of Medical Products, Roszdravnadzor, Slavyanskay sq., 4-1, 109074 Moscow, Russia.
³ Information and Methodological Center for Expertise, Stocktaking and Analysis of Circulation of Medical Products, Roszdravnadzor, Slavyanskay sq., 4-1, 109074 Moscow, Russia; I.M. Sechenov First Moscow State Medical University, 2-4 Bolshaya Pirogovskaya Str., 2-4, 119991 Moscow, Russia.
⁴ Semenov Federal Research Center for Chemical Physics RAS, Kosygin 4, 119991 Moscow, Russia.
⁵ National Wine and Grape Industry Centre, Charles Sturt University, 2650 Wagga Wagga, Australia; ChemHouse Research Group, Montpellier, France. Electronic address: Douglas.Neil.Rutledge@gmail.com.

PMID: 35803016
DOI: 10.1016/j.jpba.2022.114917

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.

Keywords: DD-SIMCA; Diclofenac sodium; Independent Components Analysis; Intact tablets; Long-term natural aging; Near InfraRed and Mid InfraRed-Attenuated Total Reflection spectroscopy.

MeSH terms

Chemometrics
Data Analysis*
Diclofenac*
Spectroscopy, Near-Infrared / methods
Tablets / chemistry

Substances

Tablets
Diclofenac