El-Abassy Omar M, Saleh Hanaa, Darwish Islam M, Bahgat Eman A
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Badr City, 11829, Cairo, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt.
Sci Rep. 2025 Jun 23;15(1):20252. doi: 10.1038/s41598-025-06157-9.
Recently, men with overactive bladder have been prescribed mirabegron and tamsulosin for the treatment of benign prostatic hyperplasia. Highly efficient and environmentally sustainable spectrophotometric methods have been developed for the accurate determination of mirabegron and tamsulosin in their pure forms as well as within pharmaceutical formulations. This study presents three effective and simple spectrophotometric methods for the simultaneous quantification of mirabegron and tamsulosin. The current protocols have demonstrated validation for linearity across concentration ranges of 3-20 µg/mL for mirabegron and 2-40 µg/mL for tamsulosin, utilizing dual wavelength, ratio difference, and derivative ratio techniques. The coefficients of determination exceeded 0.999. The validation of these methodologies was conducted in accordance with the guidelines set forth by the International council for Harmonization (ICH). Quality control laboratories may utilize existing techniques to identify the binary combination because of their high accuracy and cheap cost. The evaluation of the environmental sustainability of the established approaches was conducted using AGREE, GAPI, MOGAPI and whiteness revealing their notable eco-friendliness. The proposed method was deemed practical after the evaluation carried out with the Blue Applicability Grade Index (BAGI) assessment.
最近，膀胱过度活动症男性患者被开了米拉贝隆和坦索罗辛用于治疗良性前列腺增生。已经开发出高效且环境可持续的分光光度法，用于准确测定纯形式以及药物制剂中的米拉贝隆和坦索罗辛。本研究提出了三种有效且简单的分光光度法，用于同时定量米拉贝隆和坦索罗辛。当前方案利用双波长、比率差和导数比率技术，已证明在米拉贝隆浓度范围为3 - 20μg/mL和坦索罗辛浓度范围为2 - 40μg/mL内具有线性验证。测定系数超过0.999。这些方法的验证是根据国际协调理事会（ICH）制定的指南进行的。质量控制实验室因其高精度和低成本，可利用现有技术识别二元组合。使用AGREE、GAPI、MOGAPI和白度对既定方法的环境可持续性进行评估，结果表明它们具有显著的生态友好性。在用蓝色适用性等级指数（BAGI）评估进行评估后，所提出的方法被认为是实用的。
