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胶束增强-绿色评估-一阶导数同步荧光光谱法用于不同基质中盐酸阿夫唑嗪和琥珀酸索利那新的同时测定:对接模拟。

Micellar-enhanced and green-assessed first-derivative synchronous spectrofluorimetric approach for concurrent determination of alfuzosin hydrochloride and solifenacin succinate in different matrices: Docking simulation.

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 City, Cairo 11829, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2023 May 15;293:122442. doi: 10.1016/j.saa.2023.122442. Epub 2023 Feb 4.

Abstract

Alfuzosin hydrochloride (AZH) is co-formulated with solifenacin succinate (SOS) in Solitral® capsules for treating prostate hyperplasia in patients with overactive bladder syndrome. Herein and for the first time, an ultrasensitive synchronous spectrofluorimetric approach coupled with first-order derivative signal processing was designed for simultaneous determination of AZH and SOS in their pure forms, newly-released pharmaceutical capsules, and human biological fluids. AZH and SOS showed their conventional emission spectra in bi-distilled water at 382 nm and 294 nm after excitation at 325 nm and 250 nm, respectively. The native fluorescence intensities of AZH and SOS were greatly enhanced through micellar formation using sodium dodecyl sulfate surfactant (2%). The proposed approach included the use of synchronous mode at Δλ of 60 nm where the overlap between the studied analytes' fluorescence spectra wasn't completely resolved. The complete resolution was achieved by derivatization of the synchronized spectra to the first-order yielding two zero-crossing points which allowed the determination of AZH and SOS simultaneously without interference at 408 nm and 321 nm, respectively. Under optimum experimental circumstances, good linearities were accomplished over the concentration ranges of (1-24) ng/mL and (4-250) ng/mL with LOD of 0.26 ng/mL and 1.31 ng/mL for AZH and SOS, respectively. The proposed approach was validated successfully according to guidelines adopted by the ICH and compared statistically with the reported LC method with no discernible differences concerning accuracy or precision at p = 0.05. Successful application of the proposed approach achieved with excellent recovery percentages for analysis of the studied analytes in different matrices (pharmaceutical capsules and biological fluids) confirms its suitability for use in QC laboratories and other bioanalytical applications. The proposed approach's greenness was evaluated using two tools namely; penalty points scoring system and green analytical procedure index (GAPI) divulging excellent greenness of this approach relative to the reported LC method. The proposed approach relied chiefly on water as the cheapest and greenest solvent.

摘要

盐酸阿夫唑嗪(AZH)与琥珀酸索利那新(SOS)联合制成 Solitral®胶囊,用于治疗膀胱过度活动症伴前列腺增生的患者。本文首次设计了一种超灵敏同步分光荧光法,结合一阶导数信号处理,用于同时测定 AZH 和 SOS 在其纯品、新上市的药用胶囊和人体生物流体中的含量。AZH 和 SOS 在双蒸水中分别于 325nm 和 250nm 激发下,于 382nm 和 294nm 处显示出其常规发射光谱。当使用十二烷基硫酸钠表面活性剂(2%)形成胶束时,AZH 和 SOS 的本征荧光强度大大增强。该方法包括在 Δλ 为 60nm 的同步模式下使用,在该模式下,研究分析物的荧光光谱之间的重叠没有完全得到解决。通过将同步光谱衍生为一阶,得到两个零交叉点,从而实现完全分辨率,这允许在 408nm 和 321nm 处分别同时测定 AZH 和 SOS,而不会产生干扰。在最佳实验条件下,AZH 和 SOS 的浓度范围分别为(1-24)ng/mL 和(4-250)ng/mL 时,均获得了良好的线性关系,LOD 分别为 0.26ng/mL 和 1.31ng/mL。该方法根据 ICH 采用的指南进行了验证,并与已报道的 LC 方法进行了统计学比较,在 p=0.05 时,在准确性和精密度方面没有明显差异。该方法在不同基质(药用胶囊和生物流体)中对研究分析物的分析取得了优异的回收率,成功地应用于 QC 实验室和其他生物分析应用,证明其适合使用。该方法的绿色性使用两种工具进行了评估,即:惩罚点评分系统和绿色分析程序指数(GAPI),与已报道的 LC 方法相比,该方法显示出极好的绿色性。该方法主要依赖于水作为最便宜和最环保的溶剂。

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