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应用不同光谱技术,以美红作为探针选择性测定达卡他韦:在药物分析中的应用。

Applying different spectroscopic techniques for the selective determination of daclatasvir using merbromin as a probe: Applications on pharmaceutical analysis.

机构信息

General Courses Unit, Faculty of Sciences and Arts, King Khalid University, Dhahran, Aljanoub, Saudi Arabia.

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Al-Azhar University, Assiut Branch, Assiut, Egypt.

出版信息

Luminescence. 2021 Sep;36(6):1544-1552. doi: 10.1002/bio.4099. Epub 2021 Jun 8.

Abstract

In this study, rapid resonance Rayleigh scattering (RRS), spectrophotometric, and spectrofluorimetric methods were performed for facile quantitation of daclatasvir dihydrochloride without interference from sofosbuvir (a co-formulated anti-hepatitis C virus drug). The proposed approaches were based on forming a binary complex between daclatasvir dihydrochloride and merbromin reagent at pH 4.1. The binary complex was measured spectrophotometrically at λ = 544 nm. The spectrofluorimetric approach relied on the quenching effect of daclatasvir dihydrochloride on the fluorescence strength of merbromin at λ = 545 nm. The RRS approach depended on augmentation in the merbromin RRS spectrum at 363 nm upon addition of daclatasvir dihydrochloride. The presented methodologies were linear over the concentration ranges 2.5-15.0, 0.2-1.6 and 0.15-3.0 μg ml with detection limits of 0.45, 0.046, and 0.036 μg ml for the spectrophotometric approach, the spectrofluorometric approach, and RRS approach, respectively. Current approaches were validated in compliance with International Council for Harmonisation guidelines and utilized practically to estimate daclatasvir dihydrochloride either in binary mixtures with sofosbuvir or in its commercial tablet dosage form with good results. Moreover, the test for content uniformity was applied successfully on commercial tablets using the current spectroscopic approaches.

摘要

在这项研究中,采用快速共振瑞利散射(RRS)、分光光度法和荧光分光光度法,在不受索非布韦(一种联合抗丙型肝炎病毒药物)干扰的情况下,简便地定量检测达卡他韦二盐酸盐。所提出的方法基于在 pH 4.1 下,达卡他韦二盐酸盐与美溴铵试剂形成二元络合物。该二元络合物在 544nm 处进行分光光度测量。荧光分光光度法方法依赖于达卡他韦二盐酸盐对美溴铵荧光强度的猝灭效应,在 545nm 处进行测量。RRS 方法依赖于加入达卡他韦二盐酸盐后美溴铵的 RRS 光谱在 363nm 处的增强。所提出的方法在浓度范围为 2.5-15.0、0.2-1.6 和 0.15-3.0μg/ml 时具有线性关系,分光光度法、荧光分光光度法和 RRS 法的检测限分别为 0.45、0.046 和 0.036μg/ml。当前方法符合国际协调理事会指南,并在实际中用于评估达卡他韦二盐酸盐在与索非布韦的二元混合物中或在其商业片剂剂型中的含量,结果良好。此外,使用当前的光谱方法成功地对商业片剂进行了含量均匀度检验。

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