Yurii I Dikansky, Andrey S Drozdov, Dmitry S Dorozhko
{"title":"Study of Electrophoresis Process in Magnetic Colloids by Magnetic Methods.","authors":"Yurii I Dikansky, Andrey S Drozdov, Dmitry S Dorozhko","doi":"10.1002/elps.70017","DOIUrl":"https://doi.org/10.1002/elps.70017","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11596,"journal":{"name":"ELECTROPHORESIS","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145244213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yongjie Li, Li Jiang, Qingyang Liu, Boxu Chen, Bin Zhuang, Lijian Zhao, Junping Han, Caixia Li
{"title":"Integrated Microfluidic System for Rapid 89-Plex Y-SNP Profiling: Development and Forensic Validation.","authors":"Yongjie Li, Li Jiang, Qingyang Liu, Boxu Chen, Bin Zhuang, Lijian Zhao, Junping Han, Caixia Li","doi":"10.1002/elps.70029","DOIUrl":"https://doi.org/10.1002/elps.70029","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11596,"journal":{"name":"ELECTROPHORESIS","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145185015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lívia Maronesi Bueno, Manoelly Oliveira Rocha, Amanda Mohr, Andreia Neves Fernandes, Martin Steppe
{"title":"Development of a Green Capillary Electrophoresis Method for Determining and Quality Control of Dapagliflozin: An Oral Hypoglycemic Agent.","authors":"Lívia Maronesi Bueno, Manoelly Oliveira Rocha, Amanda Mohr, Andreia Neves Fernandes, Martin Steppe","doi":"10.1002/elps.70042","DOIUrl":"https://doi.org/10.1002/elps.70042","url":null,"abstract":"<p><p>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<sup>-1</sup> (R<sup>2</sup> > 0.999), with the limit of detection (LOD) and limit of quantitation (LOQ) of 6.2 and 18.8 µg mL<sup>-1</sup>, 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.</p>","PeriodicalId":11596,"journal":{"name":"ELECTROPHORESIS","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Evrim Ümit Kuzucu, Valentin Schittny, Jörg Huwyler, Maria Anna Schwarz
{"title":"Capillary-Based Physicochemical Characterization of Lipid Nanoparticles.","authors":"Evrim Ümit Kuzucu, Valentin Schittny, Jörg Huwyler, Maria Anna Schwarz","doi":"10.1002/elps.70032","DOIUrl":"https://doi.org/10.1002/elps.70032","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11596,"journal":{"name":"ELECTROPHORESIS","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zhiqi Wen, Ihtesham Ur Rehman, David Devolder, Astrid Eggerickx, Ann Van Schepdael, Erwin Adams
{"title":"Application of Ion Chromatography for Determination of Inorganic Ions and Sorbitol in Phosphate Syrup.","authors":"Zhiqi Wen, Ihtesham Ur Rehman, David Devolder, Astrid Eggerickx, Ann Van Schepdael, Erwin Adams","doi":"10.1002/elps.70044","DOIUrl":"https://doi.org/10.1002/elps.70044","url":null,"abstract":"<p><p>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%.</p>","PeriodicalId":11596,"journal":{"name":"ELECTROPHORESIS","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kai Zhao, Ang Li, Bing Yang, Yiyang Huo, Mengrao Tang, Yi Zhang, Junsheng Wang
{"title":"Tunable Manipulation and Separation of Microtarget by Microdroplet-Based DC-DEP.","authors":"Kai Zhao, Ang Li, Bing Yang, Yiyang Huo, Mengrao Tang, Yi Zhang, Junsheng Wang","doi":"10.1002/elps.70043","DOIUrl":"https://doi.org/10.1002/elps.70043","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11596,"journal":{"name":"ELECTROPHORESIS","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Afnan Altwala, Ayman M Algohary, Mona H Alhalafi, Mostafa M Eraqi, Ahmed M Ibrahim
{"title":"An ICH Q14-Guided AQbD Framework for the Development of an HPLC Method: Analysis of Siponimod Fumarate and Its Impurities.","authors":"Afnan Altwala, Ayman M Algohary, Mona H Alhalafi, Mostafa M Eraqi, Ahmed M Ibrahim","doi":"10.1002/elps.70039","DOIUrl":"https://doi.org/10.1002/elps.70039","url":null,"abstract":"<p><p>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<sup>-1</sup>, 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.</p>","PeriodicalId":11596,"journal":{"name":"ELECTROPHORESIS","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joanne Baxter, Lori Fitton, Cari E S van de Griend
{"title":"Towards an Analytical Procedure Control Strategy for the Capillary Zone Electrophoresis Method for Monoclonal Antibodies: Alternatives for ε-Aminocaproic Acid and Triethylenetetramine.","authors":"Joanne Baxter, Lori Fitton, Cari E S van de Griend","doi":"10.1002/elps.70038","DOIUrl":"https://doi.org/10.1002/elps.70038","url":null,"abstract":"<p><p>The ICH guideline Q14 on analytical procedure development underlines the importance of science and risk-based methods for the evaluation of the quality of medicines. Ultimately, a pharmaceutical company, the sponsor, is responsible that the analytical method is fit-for-purpose during routine use throughout its lifecycle. Part of the analytical procedure control strategy is the responsibility to assure availability of critical materials of the analytical method. For capillary zone electrophoresis (CZE) methods, the background electrolyte (BGE) composition is a key and critical material. In this study, we investigated whether key ingredients of the ε-aminocaproic acid (eACA) CZE (eACA-CZE) method for monoclonal antibodies can be replaced by structurally related chemicals. The complex heterogeneity patterns are compared, as well as the reportable results as the percentage main, acidic and basic peaks. Overall, the results underline the ruggedness of the eACA-CZE method and provide alternative options to eACA and triethyltetramine (TETA), in case there are quality or supply issues, thus de-risking and safeguarding release and stability studies for therapeutic mAbs.</p>","PeriodicalId":11596,"journal":{"name":"ELECTROPHORESIS","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}