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导数同步荧光光谱法:在分析两种含有可待因的制剂的二元混合物中的应用。

Derivative synchronous spectrofluorimetry: Application to the analysis of two binary mixtures containing codeine in dosage forms.

机构信息

Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, El-Messalah, Alexandria 21521, Egypt.

Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, El-Messalah, Alexandria 21521, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2018 Nov 5;204:677-684. doi: 10.1016/j.saa.2018.06.102. Epub 2018 Jun 27.

DOI:10.1016/j.saa.2018.06.102
PMID:29982159
Abstract

Two binary mixtures containing codeine (COD) with either ibuprofen (IBU), mixture 1, or with phenylephrine hydrochloride (PE), mixture 2, were analyzed using three simple eco-friendly spectrofluorimetric methods without the need to a prior separation step. The first method is derivative emission spectrofluorimetry using λ = 236 nm and 275 nm for mixtures 1 and 2, respectively. The second method is constant-wavelength synchronous spectrofluorimetry using ∆λ = 100 nm and 60 nm for mixtures 1 and 2, respectively. The last method is constant-energy synchronous spectrofluorimetry where a wave number interval of -7000 cm was used for the analysis of the two binary mixtures. All measurements were performed in acetate buffer pH 5 and thus no toxic volatile solvents were used increasing method greenness. High sensitivity was attained for the three studied drugs where the lower limits of quantitation of COD, IBU and PE reached 0.064, 0.512 and 0.087 μg/mL, respectively. Analysis of the two binary mixtures in their tablet and liquid dosage forms was performed with good accuracy and precision using the developed methods. The results of the proposed and reported methods were statistically evaluated using one-way ANOVA test and no significant difference among them was obtained. In addition, all aspects of ICH guidelines on analytical method validation were conducted.

摘要

两种含有可待因(COD)的二元混合物,一种与布洛芬(IBU)混合,混合物 1,另一种与盐酸苯肾上腺素(PE)混合,混合物 2,使用三种简单的环保分光荧光光度法进行分析,无需预先进行分离步骤。第一种方法是导数发射分光荧光法,混合物 1 和 2 的 λ=236nm 和 275nm。第二种方法是等波长同步分光荧光法,混合物 1 和 2 的 ∆λ=100nm 和 60nm。最后一种方法是等能量同步分光荧光法,其中两种二元混合物的波数间隔为-7000cm。所有测量均在乙酸盐缓冲液 pH 5 中进行,因此没有使用有毒挥发性溶剂,增加了方法的环保性。三种研究药物的灵敏度都很高,COD、IBU 和 PE 的定量下限分别达到 0.064、0.512 和 0.087μg/mL。用所开发的方法对片剂和液体剂型的两种二元混合物进行分析,具有良好的准确性和精密度。使用单向方差分析(one-way ANOVA test)对所提出和报告的方法的结果进行了统计评估,结果没有显著差异。此外,还对分析方法验证的 ICH 指南的所有方面进行了评估。

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