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基于简单数学过滤和经典方法的智能紫外分光光度法同时测定他索罗辛和索利那新:疗效和光谱分辨率的比较研究。

Smart UV spectrophotometric methods based on simple mathematical filtration and classical methods for the simultaneous determination of tamsulosin and solifenacin: A comparative study of efficacy and spectral resolution.

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Zagazig 44519, Egypt.

Pharmaceutical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Badr, 11829 City Cairo, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2021 Feb 15;247:119151. doi: 10.1016/j.saa.2020.119151. Epub 2020 Nov 4.

DOI:10.1016/j.saa.2020.119151
PMID:33188970
Abstract

Treatment protocols combining tamsulosin and solifenacin proved better management of the complicated urinary tract symptoms. The pharmaceutical preparations of tamsulosin and solifenacin suffered from the high difference in their ratio, 0.4 mg tamsulosin and 6 mg solifenacin, and strong spectral overlap. Here, we developed four simple, accurate and selective spectrophotometric methods based on simple mathematical manipulations. These methods require the simplest mathematical filtration using short steps performed using built-in functions of the spectrophotometer operating software utilizing zero-order or derivative spectra. These methods are namely absorption correction method (ACM), induced dual-wavelength (IDW), absorptivity factor method (AFM) and first derivative method (D1). The linear ranges were 15-70 µg/ml and 100-1200 µg/ml for TAM and SFN, respectively. The limits of quantitation were in the range of 3.8-4.05 µg/ml and 23.34-59.05 µg/ml, while the limits of detection were in the range of 1.25-1.34 µg/ml and 7.7-24.6 µg/ml for TAM and SFN, respectively. All validation parameters investigated as per ICH guidelines. A statistical comparison executed for the proposed methods with each other and with the reported methods showed no significant difference between the proposed and the reported methods.

摘要

联合坦索罗辛和索利那新的治疗方案被证明可以更好地治疗复杂的尿路症状。坦索罗辛和索利那新的药物制剂存在很大的比例差异,0.4mg 坦索罗辛和 6mg 索利那新,以及强烈的光谱重叠。在这里,我们开发了四种简单、准确和选择性的分光光度法,基于简单的数学操作。这些方法需要使用分光光度计操作软件中内置的函数进行最简单的数学过滤,使用短步骤执行,利用零阶或导数光谱。这些方法分别是吸收校正法(ACM)、诱导双波长法(IDW)、吸光度因子法(AFM)和一阶导数法(D1)。TAM 和 SFN 的线性范围分别为 15-70μg/ml 和 100-1200μg/ml。定量限范围分别为 3.8-4.05μg/ml 和 23.34-59.05μg/ml,而检测限范围分别为 1.25-1.34μg/ml 和 7.7-24.6μg/ml。所有验证参数均按照 ICH 指南进行了研究。对所提出的方法与其他方法以及与报道的方法进行了统计学比较,结果表明所提出的方法与报道的方法之间没有显著差异。

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