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Editorial Board: Electrophoresis 17F25 编辑委员会:电泳17F25
IF 2.5 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS Pub Date : 2025-10-11 DOI: 10.1002/elps.70048
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引用次数: 0
Study of Electrophoresis Process in Magnetic Colloids by Magnetic Methods 磁性胶体电泳过程的磁法研究。
IF 2.5 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS Pub Date : 2025-10-07 DOI: 10.1002/elps.70017
Yurii I. Dikansky, Andrey S. Drozdov, Dmitry S. Dorozhko

Electrokinetic phenomena play a vital role in the study of colloidal nanoparticles, offering significant insights and applications across a wide range of fundamental research and practical uses. It is crucial to recognize the extensive research on various types of nanomaterials, including polymer latexes, quantum dots, and biomolecules. However, there is a significant gap in the study of magnetic systems. Such materials have immense potential and can greatly benefit from both magnetophoretic and electrophoretic techniques. In this work, the electrophoretic behavior of water-based magnetic fluids was investigated, focusing on how additional magnetic field exposure affects their properties. The studies conducted utilized magnetic measurements that emerged from the presence of colloidal particles within the examined systems, which exhibited both charge and magnetic moment. The magnetic susceptibility and magnetization of colloidal particles precipitate formed on one of the electrodes were measured. The thickness of the formed precipitate on the electrode can be confidently estimated through micrometric measurements as well as by analyzing its magnetic susceptibility during electrophoresis. A formula for calculating the electrophoretic velocity based on the results of magnetic measurements was obtained. Estimates of zeta potential and charge of colloidal particles were carried out. The electrophoresis process in these systems can be effectively regulated by an inhomogeneous magnetic field, leading to complete compensation.

电动现象在胶体纳米颗粒的研究中起着至关重要的作用,在广泛的基础研究和实际应用中提供了重要的见解和应用。重要的是要认识到各种类型的纳米材料的广泛研究,包括聚合物乳胶、量子点和生物分子。然而,在磁系统的研究中有一个显著的空白。这种材料具有巨大的潜力,可以从磁电泳和电泳技术中获益。在这项工作中,研究了水基磁性流体的电泳行为,重点研究了额外磁场暴露对其性能的影响。这项研究利用了磁性测量,这些测量来自于被检测系统中胶体粒子的存在,它们同时表现出电荷和磁矩。测量了在其中一个电极上形成的胶体颗粒的磁化率和磁化强度。通过显微测量和电泳过程中对其磁化率的分析,可以确定电极上形成的沉淀物的厚度。根据磁测结果,得到了计算电泳速度的公式。对胶体粒子的zeta电位和电荷进行了估计。在这些系统中,电泳过程可以被一个不均匀的磁场有效地调节,从而实现完全补偿。
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引用次数: 0
Integrated Microfluidic System for Rapid 89-Plex Y-SNP Profiling: Development and Forensic Validation 集成微流体系统快速89-Plex Y-SNP分析:发展和法医验证。
IF 2.5 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS Pub Date : 2025-09-29 DOI: 10.1002/elps.70029
Yongjie Li, Li Jiang, Qingyang Liu, Boxu Chen, Bin Zhuang, Lijian Zhao, Junping Han, Caixia Li

Current Y-chromosomal single-nucleotide polymorphism (Y-SNP) detection technologies in forensic genetics often rely on bulky equipment, complex procedures, and lack adaptability to field conditions. To address these limitations, we developed an 89-plex microfluidic Y-SNP system comprising a disposable DNA extraction/amplification chip and a capillary electrophoresis chip. Using in situ lyophilization, the reagents are stabilized for long-term storage. Integrated with a portable device, the system enables a fully automated “sample-in-answer-out” workflow and delivers complete 89-locus Y-SNP genotyping within 139 min. The system includes two panels—AIYSNP42 for global high-frequency haplogroups and AIYSNP47 for East Asian O-haplogroup subclades—designed on the basis of the International Society of Genetic Genealogy (ISOGG) phylogenetic tree for multi-level resolution. Validation showed a detection sensitivity of 2.5 ng of DNA, with a 93.6% genotyping success rate across 94 forensic samples. It maintained performance under environmental inhibitors (humic acid ≤ 100 ng/µL, hemin ≤ 300 µM, indigo ≤ 15 mM) and moderate UV-induced DNA degradation. The system demonstrated excellent reproducibility (coefficient of variation, CV < 0.5%) and reliably detected male DNA in mixtures (≥2% in male–female, ≥33% in male–male). This microfluidic system reduces the reliance on the need for conventional laboratory workflows and supports rapid, on-site Y-SNP analysis for pedigree tracing, ancestry inference, and mixture interpretation.

目前法医遗传学中的y染色体单核苷酸多态性(Y-SNP)检测技术往往依赖于笨重的设备,复杂的程序,缺乏对现场条件的适应性。为了解决这些限制,我们开发了一个89 plex的微流体Y-SNP系统,包括一个一次性DNA提取/扩增芯片和一个毛细管电泳芯片。使用原位冻干,试剂被稳定为长期储存。该系统与便携式设备集成,可实现全自动“样品输入-答案输出”工作流程,并在139分钟内提供完整的89个位点Y-SNP基因分型。该系统包括全球高频单倍群的aiysnp42和东亚o -单倍群亚支的AIYSNP47两个面板,基于国际遗传谱系学会(ISOGG)系统发育树设计,具有多级分辨率。验证表明,检测灵敏度为2.5 ng DNA, 94份法医样本的基因分型成功率为93.6%。它在环境抑制剂(腐植酸≤100 ng/µL,血红素≤300µM,靛蓝≤15 mM)和中等紫外线诱导的DNA降解下保持性能。该系统具有良好的重复性(变异系数,CV)
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引用次数: 0
Editorial Board: Electrophoresis 16F25 编辑委员会:电泳16F25
IF 2.5 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS Pub Date : 2025-09-29 DOI: 10.1002/elps.70046
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引用次数: 0
Development of a Green Capillary Electrophoresis Method for Determining and Quality Control of Dapagliflozin: An Oral Hypoglycemic Agent 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。
IF 2.5 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS Pub Date : 2025-09-28 DOI: 10.1002/elps.70042
Lívia Maronesi Bueno, Manoelly Oliveira Rocha, Amanda Mohr, Andreia Neves Fernandes, Martin Steppe

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.

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。
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引用次数: 0
Capillary-Based Physicochemical Characterization of Lipid Nanoparticles 基于毛细管的脂质纳米颗粒的物理化学表征。
IF 2.5 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS Pub Date : 2025-09-28 DOI: 10.1002/elps.70032
Evrim Ümit Kuzucu, Valentin Schittny, Jörg Huwyler, Maria Anna Schwarz

Lipid nanoparticles (LNPs) are widely used for the delivery of nucleic acid (NAs), most notably in gene therapy and messenger ribonucleic acid (mRNA)-based vaccines. Understanding their physicochemical properties is essential, yet current analytical approaches often fall short in capturing their complexity. Here, we introduce an analytical strategy using capillary zone electrophoresis (CZE) and pressure-driven Taylor dispersion (TD) analysis beside the combination of both separation principles. This novel separation mode of electrophoretic TD or electrohydrodynamic coupling (termed here as eTD) can be used to characterize deoxyribonucleic acid (DNA)-loaded LNP formulations using standard capillary electrophoresis (CE) instrumentation. eTD is a new separation approach that combines electrophoretic and hydrodynamic movement in micro-scaled capillaries for the analysis of drug carriers as LNPs. Focusing on critical quality attributes (CQAs), TD provided information on the hydrodynamic radius of LNPs and the distribution of NAs across different chemical environments. CZE enabled the estimation of ζ-potential and localization of DNA within distinct particle populations. The novel eTD mode offers deeper insight into LNP structure and morphological aspects, yielding characteristic profiles for individual formulations and revealing the presence of unencapsulated DNA. To contextualize LNP measurements, we also analysed free NAs and their mixtures with LNPs under identical conditions. The method distinguished between encapsulated and unencapsulated species, revealing individual electrophoretic and dispersion profiles for single-stranded mRNA and double-stranded DNA. These findings demonstrate the potential of capillary techniques for the advanced physicochemical characterization of NA-loaded LNPs. Further investigations are warranted to expand their analytical utility and deepen our understanding of LNP structural features.

脂质纳米颗粒(LNPs)广泛用于核酸(NAs)的递送,尤其是在基因治疗和基于信使核糖核酸(mRNA)的疫苗中。了解它们的物理化学性质是必不可少的,但目前的分析方法往往无法捕捉到它们的复杂性。本文介绍了毛细管区带电泳(CZE)和压力驱动泰勒分散(TD)分析相结合的分析策略。这种新型的电泳TD或电流体动力耦合分离模式(这里称为eTD)可用于使用标准毛细管电泳(CE)仪器表征负载脱氧核糖核酸(DNA)的LNP配方。eTD是一种结合了微尺度毛细管电泳和流体动力学运动的新型分离方法,用于分析作为LNPs的药物载体。TD侧重于关键质量属性(cqa),提供LNPs的流体动力半径和NAs在不同化学环境中的分布信息。CZE能够估计ζ-电位和DNA在不同粒子群体中的定位。新的eTD模式提供了对LNP结构和形态方面的更深入的了解,产生了单个配方的特征剖面,并揭示了未封装DNA的存在。为了结合LNP测量结果,我们还在相同条件下分析了游离NAs及其与LNPs的混合物。该方法区分了被封装和未封装的物种,揭示了单链mRNA和双链DNA的个体电泳和分散谱。这些发现证明了毛细管技术对na负载LNPs进行高级物理化学表征的潜力。进一步的研究是必要的,以扩大其分析效用和加深我们对LNP结构特征的理解。
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引用次数: 0
Tunable Manipulation and Separation of Microtarget by Microdroplet-Based DC-DEP 基于微滴的DC-DEP微靶可调操作与分离。
IF 2.5 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS Pub Date : 2025-09-28 DOI: 10.1002/elps.70043
Kai Zhao, Ang Li, Bing Yang, Yiyang Huo, Mengrao Tang, Yi Zhang, Junsheng Wang

A novel DC-dielectrophoresis (DEP) method employing a tunable insulating microdroplet for the continuous sorting of microtargets is presented in this article. To induce the dielectrophoretic effect, a DC electric voltage is applied via the microdroplet through the microchannel to induce the gradient of the inhomogeneous electric field. When passing through the gap between the microdroplet and the channel where there is the strongest nonuniformity of the electric field, the microparticles experience the DEP effects, and their trajectories shift. The effects of the gap spacing and the applied voltage on the distribution of the electric field gradient and the effect of the flow rate on the particle trajectory were analyzed numerically. On the basis of theoretical analysis, a tunable microdroplet-based microfluidic chip was fabricated, and the experimental system platform centered on the tunable droplet chip was constructed. Experiments were conducted to demonstrate the sorting of 5 and 10 µm polystyrene microparticles by adjusting the joint gap distance, flow rate, and applied voltage. The experimental results were in good agreement with the numerical simulation, which proved the feasibility of using microdroplet to serve as tunable insulator for the manipulation and separation of microtargets.

本文提出了一种采用可调绝缘微滴连续分选微靶的新型直流介电电泳(DEP)方法。为了诱导介电泳效应,通过微液滴通过微通道施加直流电压来诱导非均匀电场的梯度。当通过微液滴与电场非均匀性最强的通道之间的间隙时,微粒子经历DEP效应,轨迹发生偏移。数值分析了间隙间距和外加电压对电场梯度分布的影响以及流速对粒子运动轨迹的影响。在理论分析的基础上,制作了基于可调微滴的微流控芯片,并构建了以该芯片为中心的实验系统平台。通过调节接头间隙距离、流速和施加电压,研究了5µm和10µm聚苯乙烯微粒的分选效果。实验结果与数值模拟结果吻合较好,证明了利用微液滴作为可调绝缘体进行微靶操纵和分离的可行性。
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引用次数: 0
Application of Ion Chromatography for Determination of Inorganic Ions and Sorbitol in Phosphate Syrup 离子色谱法测定磷酸糖浆中无机离子和山梨醇。
IF 2.5 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS Pub Date : 2025-09-28 DOI: 10.1002/elps.70044
Zhiqi Wen, Ihtesham Ur Rehman, David Devolder, Astrid Eggerickx, Ann Van Schepdael, Erwin Adams

In this study, ion chromatography (IC) methods were developed and validated for the determination of sodium, potassium, phosphate, and sorbitol in phosphate syrup. For the analysis of cations, an IonPac CS16 column was utilized, with a mobile phase of 50 mM methanesulfonic acid and a flow rate of 0.5 mL/min. For the analysis of phosphate and sorbitol, an IonPac AS19 column was employed, using a flow rate of 1.0 mL/min and mobile phases of 50 and 20 mM NaOH, respectively. In the validation tests, sensitivity was assessed on the basis of the signal-to-noise ratio, with the limit of detection for all analytes being below 0.001 mM. The linearity curves for all analytes exhibited determination coefficients greater than 0.999, indicating excellent linearity. The relative standard deviation (RSD%) for both inter-day and intra-day precision was not more than 1%. Accuracy, expressed as recovery (%), ranged from 98% to 101% for all ions. The validation of these methods demonstrated their reliability for the measurement of these four analytes. Furthermore, the stability of the syrup was evaluated over 6 months at room temperature (25°C). The results indicated that the phosphate syrup remained stable under these conditions, with the analyte contents staying close to 100%.

本研究建立并验证了离子色谱法测定磷酸糖浆中钠、钾、磷酸盐和山梨醇的方法。离子分析采用IonPac CS16色谱柱,流动相为50 mM甲磺酸,流速为0.5 mL/min。磷酸盐和山梨醇的分析采用IonPac AS19色谱柱,流速为1.0 mL/min,流动相分别为50和20 mM NaOH。在验证试验中,以信噪比评价灵敏度,所有分析物的检出限均小于0.001 mM,所有分析物的线性曲线的测定系数均大于0.999,表明线性良好。日间和日内精密度的相对标准偏差(RSD%)均不大于1%。准确度,表示为回收率(%),范围从98%到101%的所有离子。这些方法的验证证明了它们测量这四种分析物的可靠性。此外,在室温(25°C)下评估了糖浆的稳定性超过6个月。结果表明,在此条件下,磷酸盐糖浆保持稳定,分析物含量接近100%。
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引用次数: 0
Editorial Board: Electrophoresis 15E25 编辑委员会:电泳15E25
IF 2.5 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS Pub Date : 2025-09-25 DOI: 10.1002/elps.70045
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引用次数: 0
An ICH Q14-Guided AQbD Framework for the Development of an HPLC Method: Analysis of Siponimod Fumarate and Its Impurities 以ICH q14为指导的AQbD框架建立富马酸西泊尼莫德及其杂质HPLC分析方法。
IF 2.5 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS Pub Date : 2025-09-23 DOI: 10.1002/elps.70039
Afnan Altwala, Ayman M. Algohary, Mona H. Alhalafi, Mostafa M. Eraqi, Ahmed M. Ibrahim

Siponimod fumarate (SIP), a potent selective S1P receptor modulator, has emerged as a critical therapeutic agent in the treatment of multiple sclerosis. Recognizing the increasing regulatory demands for robust impurity profiling and method reliability, this study reports the development and optimization of an HPLC method for the simultaneous determination of SIP and its related impurities in both bulk drug substance and tablet dosage forms. The method was developed within an Analytical Quality by Design (AQbD) framework, guided by ICH Q14 principles, ensuring a systematic and risk-based approach throughout the analytical lifecycle. Chromatographic separation necessary for resolving critical impurities was achieved on an XSelect HSS T3 column (150 mm × 4.6 mm, 3.5 µm) using a stepped gradient elution program with 0.1% perchloric acid in water and acetonitrile as the mobile phases. Optimal separation conditions, identified through the AQbD process to meet stringent performance criteria, were determined at a column temperature of 42.5°C, a flow rate of 1.4 mL min−1, and UV detection at 212 nm. The method performance was rigorously evaluated through accuracy profiles, confirming both its precision and trueness across the targeted concentration range. In parallel, as part of a holistic method characterization, environmental sustainability was assessed using comprehensive greenness metrics, whereas its practical applicability was further substantiated using the Blue Applicability Grade Index (BAGI) and the Red–Green–Blue 12 (RGB12) algorithms. This approach not only bridges the gap created by the absence of an official pharmacopoeial monograph for SIP but also offers a robust, well-characterized, and sustainable platform for pharmaceutical quality control, aligning method development with both regulatory performance needs and environmental awareness.

富马酸Siponimod (SIP)是一种有效的选择性S1P受体调节剂,已成为治疗多发性硬化症的重要药物。考虑到对稳定的杂质分析和方法可靠性的日益增长的监管要求,本研究报告了同时测定原料药和片剂剂型中SIP及其相关杂质的高效液相色谱方法的开发和优化。该方法是在ICH Q14原则指导下,在分析质量设计(AQbD)框架内开发的,确保在整个分析生命周期中采用系统和基于风险的方法。在XSelect HSS T3色谱柱(150 mm × 4.6 mm, 3.5µm)上,以0.1%高氯酸水溶液和乙腈为流动相,采用阶梯式梯度洗脱程序,实现了关键杂质的分离。在柱温42.5℃,流速1.4 mL min-1,紫外检测波长212 nm的条件下,通过AQbD工艺确定了符合严格性能标准的最佳分离条件。通过准确度曲线对该方法的性能进行了严格的评价,确认了该方法在目标浓度范围内的精密度和准确度。同时,作为整体方法表征的一部分,使用综合绿色指标评估环境可持续性,而使用蓝色适用性等级指数(BAGI)和红绿蓝12 (RGB12)算法进一步证实其实际适用性。这种方法不仅弥补了SIP缺乏官方药典专著所造成的差距,而且还为药品质量控制提供了一个强大的、特征良好的、可持续的平台,使方法开发与监管绩效需求和环境意识相一致。
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引用次数: 0
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