Innovative green stability-indicating HPLC method coupled with fluorescence detection for determination of antidiabetic agent canagliflozin

IF 4.1 Q1 CHEMISTRY, ANALYTICAL
Nada Nabil , Ghada A. Sedik , Hala E. Zaazaa , Sally S. El-Mosallamy
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引用次数: 0

Abstract

This study exhibits a sustainable, easy, and reliable stability indicating HPLC approach utilizing fluorometric detection for quantification of canagliflozin (CANA) in the presence of its hepatotoxic oxidative degradation product (OXD). The chromatographic separation was accomplished using Symmetry® C18 column (3.5 μm, 4.6 × 100 mm). The mobile phase consists of 0.1 M phosphate buffer pH 2 and ethanol (40:60 v/v) pumped at a flow rate of 1.0 mL/min throughout the run. The eluted peaks were monitored by the fluorescence detector, and the chromatogram was extracted at emission wavelength of 410 nm for CANA and OXD after excitation at 290 nm which was suitable for both CANA and OXD. Performance of the suggested approach was assessed in accordance with ICH guidelines for linearity, accuracy, precision, robustness, detection, and quantitation limits. Linear relationship was achieved in the range of 0.50–10.00 μg/mL and 0.10–2.00 μg/mL for CANA and OXD, respectively with correlation coefficient 0.9999 for both components. The validated method was effectively utilized for the analysis of CANA in its pure form and drug tablets. The environmental sustainability of the suggested approach was evaluated and validated using various tools, including the analytical eco-scale, the Green Analytical Procedure Index (GAPI), and AGREE. Additional applications were employed to evaluate the ideas of 'blueness' and 'whiteness' through the newly developed Blue Applicability Grade Index (BAGI) and Red-Green-Blue 12 (RGB 12) algorithms. The elevated BAGI score (85) signified exceptional applicability, while the RGB12 score (92.2) verified the cost-effectiveness and sustainability of the used approach.

Abstract Image

创新绿色稳定性指示高效液相色谱法联合荧光检测降糖药卡格列净的含量
本研究展示了一种可持续、简单、可靠、稳定的高效液相色谱方法,该方法利用荧光检测法在肝毒性氧化降解产物(OXD)存在的情况下定量canag列净(CANA)。采用Symmetry®C18色谱柱(3.5 μm, 4.6 × 100 mm)进行色谱分离。流动相由0.1 M磷酸盐缓冲液pH 2和乙醇(40:60 v/v)组成,在整个运行过程中以1.0 mL/min的流速泵送。用荧光检测器监测洗脱峰,290 nm激发后,在410 nm的发射波长提取CANA和OXD的色谱图。根据ICH指南对建议方法的线性、准确度、精密度、鲁棒性、检测和定量限进行了评估。CANA和OXD在0.50 ~ 10.00 μg/mL和0.10 ~ 2.00 μg/mL范围内呈良好的线性关系,相关系数为0.9999。该方法可用于CANA纯品和片剂的分析。使用各种工具对建议方法的环境可持续性进行了评估和验证,包括分析生态尺度、绿色分析程序指数(GAPI)和AGREE。通过新开发的蓝色适用性等级指数(BAGI)和红绿蓝12 (RGB 12)算法,采用了其他应用程序来评估“蓝”和“白”的概念。BAGI得分(85)的提高表明了特殊的适用性,而RGB12得分(92.2)验证了所使用方法的成本效益和可持续性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Talanta Open
Talanta Open Chemistry-Analytical Chemistry
CiteScore
5.20
自引率
0.00%
发文量
86
审稿时长
49 days
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