In-Field Implementation of Near-Infrared Quantitative Methods for Analysis of Medicines in Tropical Environments.

Autor:	Waffo Tchounga CA; Department of Pharmacy, University of Liège (ULiège), CIRM, ViBra-Santé hub, Laboratory of Pharmaceutical Analytical Chemistry, Liège, Belgium.; Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon., Marini RD; Department of Pharmacy, University of Liège (ULiège), CIRM, ViBra-Santé hub, Laboratory of Pharmaceutical Analytical Chemistry, Liège, Belgium., Nnanga Nga E; Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon., Ciza Hamuli P; Faculty of Pharmaceutical Sciences, University of Kinshasa, Lemba, Kinshasa, Democratic Republic of the Congo., Ngono Mballa R; Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.; Laboratoire National de Contrôle des Médicaments et Expertise (LANACOME), Yaoundé, Cameroon., Hubert P; Department of Pharmacy, University of Liège (ULiège), CIRM, ViBra-Santé hub, Laboratory of Pharmaceutical Analytical Chemistry, Liège, Belgium., Ziemons E; Department of Pharmacy, University of Liège (ULiège), CIRM, ViBra-Santé hub, Laboratory of Pharmaceutical Analytical Chemistry, Liège, Belgium., Sacré PY; Department of Pharmacy, University of Liège (ULiège), CIRM, Research Support Unit in Chemometrics, Liège, Belgium.
Jazyk:	angličtina
Zdroj:	Applied spectroscopy [Appl Spectrosc] 2023 Nov; Vol. 77 (11), pp. 1264-1279. Date of Electronic Publication: 2023 Sep 21.
DOI:	10.1177/00037028231201653
Abstrakt:	Near-infrared (NIR) spectroscopy is actually a well-established technique that demonstrates its performance in the frame of detection of poor-quality medicines. The use of low-cost handheld NIR spectrophotometers in low-resource contexts can allow an inexpensive and more rapid detection compared to laboratory methods. Considering these points, it was decided to develop, validate, and transfer methods for the quantification of ciprofloxacin and metronidazole tablet samples using a NIR handheld spectrophotometer in transmission mode (NIR-M-T1) coupled to chemometrics such as partial least squares regression (PLSR) algorithm. All of the models were validated with the total error approach using an accuracy profile as a decision tool, with ±10% specifications and a risk α set at 5%. Quantitative PLSR models were first validated in Belgium, which is a temperate oceanic climate zone. Second, they were transferred to Cameroon, a tropical climate zone, where issues regarding the prediction of new validation series with the initial models were highlighted. Two augmentation strategies were then envisaged to make the predictive models robust to environmental conditions, incorporating the potential variability linked to environmental effects in the initial calibration sets. The resulting models were then used for in-field analysis of ciprofloxacin and metronidazole tablet samples collected in three cities in Cameroon. The contents results obtained for each sample with the two strategies were close and not statistically different. Nevertheless, the first one is easier to implement and the second is the best regarding model diagnostic measures and accuracy profiles. Two samples were found to be noncompliant in terms of content, and these results were confirmed using high-performance liquid chromatography taken as the reference method. Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Databáze:	MEDLINE
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