Characterization of the degradation of dipyrone (metamizole) in expired oral pharmaceutical products by Raman spectroscopy and principal component analysis (PCA)

IF 1.3 4区工程技术 Q4 CHEMISTRY, ANALYTICAL

Instrumentation Science & Technology Pub Date : 2022-12-22 DOI:10.1080/10739149.2022.2158857

L. Guimarães, Leandra Paula Marques de Sousa Rosa Nita, W. Toma, M. T. Pacheco, L. Silveira

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Abstract

Abstract Stability studies are essential to ensure that a drug maintains its qualities after leaving the production line until the end of the validity date. This study aimed to identify the alterations related to shelf time in commercial formulations containing dipyrone (metamizole) and to model the shelf time by Raman spectroscopy (830 nm, 350 mW). Spectra of nine commercial medicines containing dipyrone sodium were obtained during the validity period (valid samples) and after the expiration date (overdue samples) with shelf times ranging from 46 to 62 months. The spectra were compared to identify changes due to the dipyrone degradation and develop a model to estimate the shelf time. The Raman analysis of valid and overdue samples showed peaks due to the hydrolysis-oxidation of dipyrone: a blue-shift (N feature in the difference spectrum) of the bands assigned to aromatic and pyrazole rings due to the presence of the metabolite N-methylaminoantipyrine, a decrease in peaks related to the dissociation of − SO3Na due to the hydrolysis/oxidation, and an increase in peaks associated with sodium sulfate/disulfate. A regression model based upon principal component analysis (PCA) showed a strong correlation between shelf time and the PCA variable PC2 (Pearson’s correlation coefficient r = 0.804). The study showed the feasibility of Raman spectroscopy in identifying the degradation of dipyrone sodium to characterize the shelf time and use in the quality control of commercial medicines.

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拉曼光谱和主成分分析（PCA）表征过期口服药品中二吡唑的降解

摘要稳定性研究对于确保药物在离开生产线后直到有效期结束前保持其质量至关重要。本研究旨在确定含有二吡咯（安乃近）的商业制剂中与保质期相关的变化，并通过拉曼光谱对保质期进行建模（830 nm，350 mW）。在有效期内（有效样品）和有效期后（过期样品），获得了9种含有双嘧酮钠的商品药的光谱，保质期从46到62 月。对光谱进行比较，以确定二吡咯烷降解引起的变化，并开发一个模型来估计保质期。有效和过期样品的拉曼分析显示，由于二吡咯的水解氧化而出现峰值：由于代谢物N-甲基氨基安替比林的存在，分配给芳香环和吡唑环的谱带发生蓝移（差异光谱中的N特征），与 − SO3Na，以及与硫酸钠/二硫酸盐相关的峰的增加。基于主成分分析（PCA）的回归模型显示，货架时间与主成分分析变量PC2之间存在很强的相关性（Pearson相关系数r = 0.804）。该研究表明拉曼光谱在鉴定二吡咯烷钠降解以表征保质期和用于商业药物质量控制方面的可行性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Instrumentation Science & Technology 工程技术-分析化学

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Instrumentation Science & Technology is an internationally acclaimed forum for fast publication of critical, peer reviewed manuscripts dealing with innovative instrument design and applications in chemistry, physics biotechnology and environmental science. Particular attention is given to state-of-the-art developments and their rapid communication to the scientific community. Emphasis is on modern instrumental concepts, though not exclusively, including detectors, sensors, data acquisition and processing, instrument control, chromatography, electrochemistry, spectroscopy of all types, electrophoresis, radiometry, relaxation methods, thermal analysis, physical property measurements, surface physics, membrane technology, microcomputer design, chip-based processes, and more. Readership includes everyone who uses instrumental techniques to conduct their research and development. They are chemists (organic, inorganic, physical, analytical, nuclear, quality control) biochemists, biotechnologists, engineers, and physicists in all of the instrumental disciplines mentioned above, in both the laboratory and chemical production environments. The journal is an important resource of instrument design and applications data.