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通过与曙红Y离子对作为荧光光谱和分光光度探针分析维立西呱:在含量均匀度测试中的应用。

Analysis of vericiguat via ion-pairing with eosin Y as a spectrofluorimetric and spectrophotometric probe: Application to content uniformity test.

作者信息

Salem Hesham, Mazen Dina Z, Hany Bassant, Raafat Hytham, Alaa Alyaa, Osama Nourhan, Magdy Maimana A

机构信息

Pharmaceutical Chemistry Department, Faculty of Pharmacy, Deraya University, New Minia, Egypt.

Pharmaceutical Chemistry Department, Faculty of Pharmacy, Deraya University, New Minia, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2025 Mar 15;329:125482. doi: 10.1016/j.saa.2024.125482. Epub 2024 Nov 29.

Abstract

Using spectroscopy, quick and sensitive analytical methods based on Eosin Y ion pairing were developed and assessed in order to determine vericiguat with high selectivity and sensitivity. The drug is used for treating symptomatic chronic heart failure (HF), The quenching impact of vericiguat on the Eosin Y's fluorescence at a pH 3.3, in 0.1 M acetate buffer solution was observed using spectrofluorometric technique. This technique is regarded as the original spectrofluorometric technique for the assay of vericiguat. The quenching effect on fluorescence was ranged from 100 to 1000 ng mL. The absorbance of the generated ion-pair was measured using spectrophotometric method at 550 nm in aqueous buffered solutions with pH 3.3. In the concentration range of 1.0-10.0 µg mL, Beer's law was followed. The two approaches were applied to the analysis of dosage forms with a high percent recovery successfully, and they were assessed in compliance with ICH guidelines. Moreover, the method's sustainability was evaluated and compared to the published method using two greenness assessment tools termed analytical eco-scale and Analytical GREENness (AGREE). That findings suggest that the method is more sustainable than the published method.

摘要

为了高选择性和高灵敏度地测定维立西呱,采用光谱法开发并评估了基于伊红Y离子对的快速灵敏分析方法。该药物用于治疗有症状的慢性心力衰竭(HF),使用荧光光谱技术观察了维立西呱在pH 3.3的0.1 M醋酸盐缓冲溶液中对伊红Y荧光的猝灭作用。该技术被视为测定维立西呱的原始荧光光谱技术。荧光猝灭效应范围为100至1000 ng/mL。在pH 3.3的水性缓冲溶液中,于550 nm处用分光光度法测量生成的离子对的吸光度。在1.0 - 10.0 μg/mL的浓度范围内符合比尔定律。这两种方法成功应用于高回收率剂型的分析,并按照ICH指南进行了评估。此外,使用称为分析生态规模和分析绿色度(AGREE)的两种绿色度评估工具对该方法的可持续性进行了评估,并与已发表的方法进行了比较。结果表明该方法比已发表的方法更具可持续性。

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