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新型生态一阶导数同步荧光分光光度法同时测定片剂中卡维地洛和伊伐布雷定的含量。

New ecological first derivative synchronous spectrofluorimetric method for simultaneous quantification of carvedilol and ivabradine in tablets.

机构信息

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

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

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2023 Mar 15;289:122074. doi: 10.1016/j.saa.2022.122074. Epub 2022 Dec 5.

Abstract

A new, rapid, selective, green, and highly sensitive method has been established to determine ivabradine and carvedilol simultaneously. The first derivative synchronous spectrofluorimetric approach was applied for the determination of the studied drugs. Assessment of the first derivative amplitude of carvedilol and ivabradine has been done at 339 nm and 298 nm respectively which are the zero crossing points of each other. The method validation is estimated and was found to be consistent with International Conference on Harmonization guidelines. Linearity was found to be in the range of 10.0 to 90.0 ng/mL for carvedilol and from 80.0 to140.0 ng/mL for ivabradine. The detection limits were found to be 1.2 ng/ mL and 3.3 ng/mL and the quantitation limits were 3.7 ng / mL and 10.0 ng /mL for carvedilol and ivabradine, respectively. The method was effectively applied for the determination of both drugs in their synthetic mixture in different ratios and in their prepared co-formulated tablets. The results were compared with those of comparison HPLC methods. Ethanol was used as a green solvent. The proposed method is suitable for the determination of ivabradine and carvedilol with satisfactory accuracy and precision. The greenness of the method was evaluated using four assessment tools, i.e. NEMI, GAPI, Eco-scale, and AGREE. The proposed method is simple with a low cost compared to HPLC methods.

摘要

一种新的、快速的、选择性的、绿色的和高灵敏度的方法已经建立,用于同时测定伊伐布雷定和卡维地洛。应用一阶导数同步荧光法测定研究药物。分别在 339nm 和 298nm 处评估卡维地洛和伊伐布雷定的一阶导数幅度,这是彼此的零交点。方法验证符合国际协调会议指南。线性范围为卡维地洛 10.0 至 90.0ng/mL,伊伐布雷定 80.0 至 140.0ng/mL。检测限分别为 1.2ng/mL 和 3.3ng/mL,定量限分别为 3.7ng/mL 和 10.0ng/mL,用于卡维地洛和伊伐布雷定。该方法有效地应用于不同比例的合成混合物和已制备的共制剂片剂中两种药物的测定。结果与比较 HPLC 方法进行了比较。乙醇被用作绿色溶剂。该方法适用于伊伐布雷定和卡维地洛的测定,具有令人满意的准确度和精密度。使用 NEMI、GAPI、Eco-scale 和 AGREE 四种评估工具对方法的绿色度进行了评估。与 HPLC 方法相比,该方法简单且成本低。

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