Pharmaceutical Chemistry Department, Faculty of Pharmacy, Future University in Egypt, Cairo, Egypt.
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo 11562, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2023 Sep 5;297:122737. doi: 10.1016/j.saa.2023.122737. Epub 2023 Apr 13.
This study presents the determination of Alcaftadine (ALF) in its oxidative degradation product presence by applying comprehensive study comparative of four different green stability indicating spectrophotometric approaches through successful exploitation of different spectrophotometric platform windows. Window I; based on absorption spectrum zero order data manipulation using the newly developed extended absorbance difference (EAD). Window II; based on derivative spectra by second order derivative (D) data manipulation. Window III; based on ratio spectra applying constant multiplication (CM) and absorptivity centering via factorized ratio difference spectrum (ACT-FSR) methods data manipulation. Finally, window IV; based on derivative of ratio spectrum by virtue of first derivative of ratio spectral (DD) method data manipulation. Calibration curves construction were over linearity range; 1.0-14.0 µg/mL for ALF. The proposed methods accuracy, precision, and linearity range were determined and validated as per ICH guidelines. Moreover, they were able to analyze ALF in raw form, dosage form and in existence of its oxidative degradation product. Statistical comparisons were done between the proposed methods and the reported one showing no significant difference concerning accuracy and precision. Furthermore, greenness profile assessment was accomplished by means of four metric tools; namely: analytical greenness (AGREE), green analytical procedure index (GAPI), analytical eco-scale, and national environmental method index (NEMI).
本研究在存在阿伐斯汀（ALF）氧化降解产物的情况下，通过成功利用不同分光光度平台窗口，对四种不同的绿色稳定指示分光光度方法进行综合比较，提出了测定阿伐斯汀的方法。窗口 I：基于新开发的扩展吸收差（EAD），对零阶吸收光谱数据进行处理。窗口 II：基于二阶导数（D）数据处理的导数光谱。窗口 III：基于比值光谱，应用常数乘法（CM）和通过因子化比值差光谱（ACT-FSR）方法进行吸光度中心化（ACT-FSR）数据处理。最后，窗口 IV：基于比值光谱的一阶导数（DD）法数据处理的导数比值光谱。ALF 的校准曲线构建范围为线性范围：1.0-14.0μg/mL。根据 ICH 指南确定并验证了所提出方法的准确性、精密度和线性范围。此外，它们能够分析原料药、制剂以及其氧化降解产物存在下的 ALF。通过四种度量工具（即：分析绿色度（AGREE）、绿色分析程序指数（GAPI）、分析生态标度和国家环境方法指数（NEMI））对绿色度进行评估。
