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基于傅里叶变换红外光谱(FT-IR)与化学计量学相结合的先进分析方法用于药物制剂的质量控制。

Advanced Analytical Approach Based on Combination of FT-IR and Chemometrics for Quality Control of Pharmaceutical Preparations.

作者信息

Foschi Martina, Marziale Mariagrazia, Biancolillo Alessandra

机构信息

Department of Physical and Chemical Sciences, University of L'Aquila, Via Vetoio, Coppito, 67100 L'Aquila, Italy.

出版信息

Pharmaceuticals (Basel). 2022 Jun 18;15(6):763. doi: 10.3390/ph15060763.

Abstract

BACKGROUND

The present work represents a feasibility study for the realization of an analytical method finalized to the detection of expired antibiotic tablets. The work focuses on a specific antibiotic drug and represents the preliminary study upstream of a larger-scale work.

METHODS

attenuated Total reflection-Fourier transform infrared spectroscopy (ATR-FTIR) spectra coupled with sequential preprocessing through an orthogonalization (SPORT) chemometric approach were used to discriminate between expired and compliant tablets.

CONCLUSIONS

The highest predictive accuracy (93.3% of correct classification rate in external validation, corresponding to 1 misclassified test sample over 15) was achieved by analyzing intact tablets. This represents an excellent result because it gives indications regarding the possibility of determining, in a completely non-destructive way, the presence of expired drugs.

摘要

背景

本研究是一项关于实现用于检测过期抗生素片剂的分析方法的可行性研究。该研究聚焦于一种特定的抗生素药物,是一项更大规模研究的前期初步研究。

方法

采用衰减全反射傅里叶变换红外光谱(ATR-FTIR)结合通过正交化(SPORT)化学计量学方法进行的顺序预处理,来区分过期片剂和合格片剂。

结论

通过分析完整片剂实现了最高的预测准确性(外部验证中正确分类率为93.3%,即15个测试样品中有1个误分类)。这是一个出色的结果,因为它表明了以完全无损的方式确定过期药物存在的可能性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63a1/9228031/9947d0c5924b/pharmaceuticals-15-00763-g001.jpg

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