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采用导数光谱法同时测定度洛西汀和阿伐那非二元混合物的新型分光光度法:绿色度-蓝色度评估

Novel spectrophotometric methods for concurrent assessment of duloxetine and avanafil in their binary mixture using derivative spectroscopy: greenness-blueness evaluation.

作者信息

Elhamdy Hadeer A, Derayea Sayed M, El-Din Khalid M Badr, Oraby Mohamed

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Sohag University, Sohag, 82524, Egypt.

Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, 61519, Egypt.

出版信息

BMC Chem. 2025 Apr 2;19(1):87. doi: 10.1186/s13065-025-01450-0.

Abstract

Antidepressant drugs, particularly selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are known to induce sexual dysfunction as a side effect. Duloxetine (DLX) and Avanafil (AVN) are simultaneously determined in their pure state and laboratory-prepared mixtures by two novel, environmentally friendly spectrophotometric methods. The first method was based on second order derivatives while the second method is based on first derivative dual-wavelength. In method I, the linearity range was found to be 0.5-12 µg/mL and 1-12 µg/mL with limit of detection 0.15 µg/mL and 0.27 µg/mL for DLX and AVN, respectively. In method II, the linearity range was found to be 1-10 µg/mL for both drugs with limit of detection 0.18 µg/mL and 0.21 µg/mL for DLX and AVN, respectively. The validation of these approaches meets the International Council for Harmonization's (ICH) standards. Furthermore, three current ecological tools namely the Eco-Scale, GAPI, and AGREE were used to evaluate the proposed method's greenness. The sustainability characteristics of the proposed method were also assessed using the Blue Applicability Grade Index (BAGI), a recently developed metric for assessing the practicality (blueness) of procedures.

摘要

已知抗抑郁药物,特别是选择性5-羟色胺再摄取抑制剂(SSRI)和5-羟色胺-去甲肾上腺素再摄取抑制剂(SNRI)会诱发性功能障碍这一边缘效应。采用两种新型环保分光光度法同时测定度洛西汀(DLX)和阿伐那非(AVN)的纯品及其实验室制备的混合物。第一种方法基于二阶导数,第二种方法基于一阶导数双波长法。在方法I中,度洛西汀和阿伐那非的线性范围分别为0.5 - 12 μg/mL和1 - 12 μg/mL,检测限分别为0.15 μg/mL和0.27 μg/mL。在方法II中,两种药物的线性范围均为1 - 10 μg/mL,度洛西汀和阿伐那非的检测限分别为0.18 μg/mL和0.21 μg/mL。这些方法的验证符合国际协调理事会(ICH)的标准。此外,使用三种当前的生态工具,即生态量表、GAPI和AGREE来评估所提出方法的绿色程度。还使用蓝色适用性等级指数(BAGI)评估了所提出方法的可持续性特征,BAGI是最近开发的一种用于评估程序实用性(蓝色程度)的指标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/095f/11966798/c2e97fe3b745/13065_2025_1450_Fig1_HTML.jpg

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