Mohamed Ahmed R, El-Hanboushy Sara, Darweish Eman
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Badr City, Cairo, 11829, Egypt.
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Future University in Egypt, Cairo, 11835, Egypt.
Sci Rep. 2025 Aug 14;15(1):29829. doi: 10.1038/s41598-025-13989-y.
Mirabegron (MIR) and silodosin (SIL) have recently been combined in a single pill to significantly enhance the effectiveness of treating detrusor hyperactivity with impaired contractility (DHIC), leading to appreciable improvements in symptoms associated with overactive bladder. Additionally, this combination effectively manages lower ureteric stones and improves patient outcomes with no significant side effects, especially in elderly patients. Accordingly, this study introduces two UV techniques for analyzing MIR and SIL in their mixtures (pure and commercial mixtures). These techniques were backed by a one-step salting-out liquid/liquid extraction (SALLE) procedure for quantifying MIR and SIL in urine samples without matrix interference. The proposed UV techniques succeeded in resolving the superimposed MIR's and SIL's UV spectra by employing straightforward mathematical filtration. The UV techniques were Fourier self-deconvolution (FSD) and induced dual-wavelength (IDW) techniques, with linearities of (50-350) µg/mL for MIR and (5-100) µg/mL for SIL. The applied techniques were verified following the International Council for Harmonisation (ICH) directives and were statistically evaluated against the published technique, with no noteworthy differences found. The applied techniques' practicality (blueness), whiteness, and greenness were appraised utilizing various metrics. Per the preceding, the applied approaches have been proven to be sustainable, delicate, and appropriate for quality control (QC) testing. Also, backing the applied approaches with the SALLE procedure enables precise monitoring of MIR and SIL in miscellaneous biological fluids with excellent recoveries, presenting an inventive approach for further bioanalytical applications.
米拉贝隆（MIR）和西洛多辛（SIL）最近被制成单片复方制剂，显著提高了治疗伴有收缩功能受损的逼尿肌过度活动症（DHIC）的疗效，使膀胱过度活动症相关症状有明显改善。此外，这种复方制剂能有效处理输尿管下段结石并改善患者预后，且无明显副作用，尤其对老年患者。因此，本研究介绍了两种用于分析MIR和SIL混合物（纯品和市售混合物）的紫外技术。这些技术辅以一步盐析液/液萃取（SALLE）程序，用于定量尿液样本中的MIR和SIL，不受基质干扰。所提出的紫外技术通过简单的数学过滤成功解析了叠加的MIR和SIL的紫外光谱。紫外技术为傅里叶自去卷积（FSD）和诱导双波长（IDW）技术，MIR的线性范围为（50 - 350）μg/mL，SIL的线性范围为（5 - 100）μg/mL。所应用的技术按照国际协调理事会（ICH）指令进行了验证，并与已发表的技术进行了统计学评估，未发现显著差异。利用各种指标评估了所应用技术的实用性（蓝色度）、白度和绿色度。根据上述内容，已证明所应用的方法具有可持续性、灵敏性且适用于质量控制（QC）检测。此外，将所应用的方法与SALLE程序相结合，能够精确监测多种生物流体中的MIR和SIL，回收率良好，为进一步的生物分析应用提供了一种创新方法。
