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一种环保、选择性和灵敏的分光荧光定量法,用于测定其散装和片剂剂型中的多替拉韦。

An eco- friendly, selective, and sensitive spectrofluorimetric method for the quantification of Dolutegravir in its bulk and tablet dosage form.

机构信息

Pharmaceutical Chemistry Department, College of Pharmacy, Prince Sattam bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2022 May 15;273:121035. doi: 10.1016/j.saa.2022.121035. Epub 2022 Feb 14.

DOI:10.1016/j.saa.2022.121035
PMID:35193000
Abstract

This study is concerned with assessing the bulk and tablet dosage forms of Dolutegravir (DTG) by means of a novel yet simple environmentally friendly spectrofluorimetric method that features fast response and high sensitivity compared to the time consuming HPLC methods and the lower sensitivity spectrophotometric ones. The method relies mainly on measuring the native fluorescence of Dolutegravir in water at an emission of 415 nm after excitation at 262 nm. The method shows rectilinear fluorescence-concentration relation over Dolutegravir concentration range of 0.2-1.2 µg/mL at the emission maxima, with detection limit of 0.020 µg/mL and quantification limit of 0.061 µg/mL. The results of the proposed method were compared with those obtained by applying the comparison method and the two sets coincided harmoniously. In addition, the method was validated in accordance with ICH guidelines for linearity, accuracy, precision, specificity, and robustness.

摘要

本研究旨在通过一种新颖而简单的环保分光荧光法评估多替拉韦(DTG)的散装和片剂剂型,与耗时的 HPLC 方法和灵敏度较低的分光光度法相比,该方法具有快速响应和高灵敏度的特点。该方法主要依赖于在 262nm 激发下,在水相中测量多替拉韦的固有荧光,在 415nm 处发射。在发射最大值处,多替拉韦浓度范围为 0.2-1.2μg/mL 时,该方法的荧光强度与浓度呈线性关系,检测限为 0.020μg/mL,定量限为 0.061μg/mL。所提出方法的结果与应用比较法获得的结果进行了比较,两组结果吻合良好。此外,该方法还按照 ICH 指南进行了线性、准确性、精密度、特异性和稳健性验证。

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