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一石二鸟:用于同时测定西洛多辛和米拉贝隆的可持续智能分光光度法:在剂型中的应用及绿色度评估

Two birds with one stone: sustainable smart spectrophotometric methods for concurrent determination of silodosin and mirabegron: application to dosage forms and greenness assessment.

作者信息

Badr El-Din Khalid M, Derayea Sayed M, Ahmed Ahmed S, Oraby Mohamed, Abdelshakour Mohamed A

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Minia University, Minia, 61519, Egypt.

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Sohag University, Sohag, 82524, Egypt.

出版信息

BMC Chem. 2025 Mar 3;19(1):56. doi: 10.1186/s13065-025-01411-7.

DOI:10.1186/s13065-025-01411-7
PMID:40025518
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11874656/
Abstract

A new combination of silodosin and mirabegron has recently obtained approval in the Indian market for addressing the benign prostatic hyperplasia symptoms associated with overactive bladder syndrome. In this study, we present four validated UV-spectrophotometric methods that rely on straightforward mathematical calculations for the quick and simultaneous assay of MRB and SLD in commercial tablets and synthetic mixes without the need for prior separation. The suggested methods include dual-wavelength, induced dual-wavelength, ratio difference, and area under the curve. These methods were effectively used to determine SLD and MRB simultaneously in combinations with severe spectrum overlap, showing excellent recoveries free from interference from pharmaceutical excipients. The proposed approaches were assessed and validated following the guidelines set forth by the International Conference for Harmonization (ICH). The methods exhibited linear ranges of 1-20 μg mL and 1-25 μg mL for SLD and MRB, respectively. Their environmental friendliness was assessed using the Analytical Greenness Calculator (AGREE) and The Green Analytical Procedure Index (GAPI) tools, demonstrating their supremacy in terms of greenness compared to the reported chromatographic method. There were no appreciable variations in accuracy or precision between the reported chromatographic method and statistical comparisons based on t- and F values. Consequently, these suggested methods are deemed effective in routine analysis of SLD and MRB, serving as cost-effective alternatives in quality control laboratories lacking expensive chromatographic instruments.

摘要

西洛多辛和米拉贝隆的新组合最近在印度市场获得批准,用于治疗与膀胱过度活动症相关的良性前列腺增生症状。在本研究中,我们提出了四种经过验证的紫外分光光度法,这些方法依靠简单的数学计算,无需事先分离即可快速同时测定市售片剂和合成混合物中的米拉贝隆(MRB)和西洛多辛(SLD)。建议的方法包括双波长法、诱导双波长法、比率差法和曲线下面积法。这些方法有效地用于在严重光谱重叠的情况下同时测定SLD和MRB,显示出优异的回收率,不受药物辅料的干扰。按照国际协调会议(ICH)制定的指南对所提出的方法进行了评估和验证。这些方法对SLD和MRB的线性范围分别为1 - 20 μg/mL和1 - 25 μg/mL。使用分析绿色度计算器(AGREE)和绿色分析程序指数(GAPI)工具评估了它们的环境友好性,结果表明与报道的色谱法相比,它们在绿色度方面具有优势。报道的色谱法与基于t值和F值的统计比较在准确度或精密度方面没有明显差异。因此,这些建议的方法被认为在SLD和MRB的常规分析中有效,是缺乏昂贵色谱仪器的质量控制实验室中具有成本效益的替代方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/3a05341f0096/13065_2025_1411_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/f097dc5e3502/13065_2025_1411_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/fced371338fa/13065_2025_1411_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/2d38cf9809df/13065_2025_1411_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/25ab05fa250c/13065_2025_1411_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/3a05341f0096/13065_2025_1411_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/f097dc5e3502/13065_2025_1411_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/fced371338fa/13065_2025_1411_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/2d38cf9809df/13065_2025_1411_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/25ab05fa250c/13065_2025_1411_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a67/11874656/3a05341f0096/13065_2025_1411_Fig5_HTML.jpg

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