Development of a Green Capillary Electrophoresis Method for Determining and Quality Control of Dapagliflozin: An Oral Hypoglycemic Agent.

IF 2.5 3区生物学 Q2 BIOCHEMICAL RESEARCH METHODS

ELECTROPHORESIS Pub Date : 2025-09-28 DOI:10.1002/elps.70042

Lívia Maronesi Bueno, Manoelly Oliveira Rocha, Amanda Mohr, Andreia Neves Fernandes, Martin Steppe

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引用次数: 0

Abstract

A green method by capillary electrophoresis (CE) is described for the first time for the determination of dapagliflozin (DAPA), an oral hypoglycemic drug approved for the treatment of Type 2 diabetes mellitus. The effects of different analytical conditions were evaluated, including the concentration and pH of the background electrolyte (BGE), sample injection time, applied voltage, as well as capillary temperature. The method was validated by establishing the linearity, intra- and interday precisions (relative standard deviation, RSD%), accuracy, and robustness. The analytical procedure was linear in the range of 50-175 µg mL^-1 (R² > 0.999), with the limit of detection (LOD) and limit of quantitation (LOQ) of 6.2 and 18.8 µg mL^-1, respectively. Precision had an intraday RSD of 2.55% and an interday RSD of 2.52%. The average recovery rates for the pharmaceutical samples ranged from 101.22% to 104.63%, with an RSD of 0.88%. Additionally, the CE method was compared to a high-performance liquid chromatography (HPLC) method for quantifying DAPA, and their green profiles were assessed by the Analytical Greenness Metric (AGREE), confirming the eco-friendliness of the CE technique. The methodology is suitable for determining DAPA in tablets; CE provides a greener alternative due to low-cost analysis using fewer organic solvents and minimizing waste generation.

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口服降糖药达格列净绿色毛细管电泳测定及质量控制方法的建立。

本文首次采用毛细管电泳（CE）绿色法测定经批准用于治疗2型糖尿病的口服降糖药达格列净（dapagliflozin， DAPA）的含量。考察了背景电解质（BGE）的浓度和pH、进样时间、外加电压和毛细管温度等不同分析条件对测定结果的影响。通过建立线性关系、日内、日间精密度（相对标准偏差，RSD%）、准确度和鲁棒性对方法进行验证。分析方法在50 ~ 175µg mL-1范围内呈线性（R2 > 0.999），检出限（LOD）为6.2µg mL-1，定量限（LOQ）为18.8µg mL-1。精密度日内RSD为2.55%，日内RSD为2.52%。平均加样回收率为101.22% ~ 104.63%，RSD为0.88%。此外，将CE法与高效液相色谱法（HPLC）进行了比较，并通过分析绿色度度量（AGREE）评估了它们的绿色特征，证实了CE技术的生态友好性。该方法适用于片剂中DAPA含量的测定；由于使用较少的有机溶剂和最大限度地减少废物产生，CE提供了一种更环保的选择。

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

ELECTROPHORESIS 生物-分析化学

CiteScore

6.30

自引率

13.80%

发文量

244

审稿时长

1.9 months

期刊介绍： ELECTROPHORESIS is an international journal that publishes original manuscripts on all aspects of electrophoresis, and liquid phase separations (e.g., HPLC, micro- and nano-LC, UHPLC, micro- and nano-fluidics, liquid-phase micro-extractions, etc.). Topics include new or improved analytical and preparative methods, sample preparation, development of theory, and innovative applications of electrophoretic and liquid phase separations methods in the study of nucleic acids, proteins, carbohydrates natural products, pharmaceuticals, food analysis, environmental species and other compounds of importance to the life sciences. Papers in the areas of microfluidics and proteomics, which are not limited to electrophoresis-based methods, will also be accepted for publication. Contributions focused on hyphenated and omics techniques are also of interest. Proteomics is within the scope, if related to its fundamentals and new technical approaches. Proteomics applications are only considered in particular cases. Papers describing the application of standard electrophoretic methods will not be considered. Papers on nanoanalysis intended for publication in ELECTROPHORESIS should focus on one or more of the following topics: • Nanoscale electrokinetics and phenomena related to electric double layer and/or confinement in nano-sized geometry • Single cell and subcellular analysis • Nanosensors and ultrasensitive detection aspects (e.g., involving quantum dots, "nanoelectrodes" or nanospray MS) • Nanoscale/nanopore DNA sequencing (next generation sequencing) • Micro- and nanoscale sample preparation • Nanoparticles and cells analyses by dielectrophoresis • Separation-based analysis using nanoparticles, nanotubes and nanowires.