{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T20:10:55Z","timestamp":1791922255358,"version":"4.3.4"},"reference-count":32,"publisher":"Wiley","issue":"23","license":[{"start":{"date-parts":[[2025,9,23]],"date-time":"2025-09-23T00:00:00Z","timestamp":1758585600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Electrophoresis"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Substandard and falsified medicines pose a significant public health threat, particularly in low\u2010income countries. Ensuring pharmaceutical quality is crucial to mitigate risks associated with ineffective and harmful medications. Among others, developing and implementing robust and cost\u2010effective analytical methods is an important and quick strategy for ensuring the quality of medicines. This study aimed to develop a robust and cost\u2010effective capillary zone electrophoresis method with UV detection for insulin analysis in active pharmaceutical ingredient and formulations. A multilayer capillary coated with polybrene and poly(sodium 4\u2010styrenesulfonate) improved repeatability. The method was optimized by systematically evaluating running buffer composition, pH, ionic strength, and voltage, achieving optimal separation with a 60\u00a0mM phosphate buffer at pH 8.0. It demonstrated excellent precision, accuracy, linearity, and robustness. Application of the method to insulin commercial samples verified compliance with pharmacopoeial standards. The method could be a reliable and accessible alternative for quality control of insulin in resource\u2010limited settings, supporting efforts to combat substandard pharmaceuticals and protect public health. Moreover, the method aligns with green chemistry principles, as it eliminates the need for organic solvents, either as solvent or as a component of the running buffer.<\/jats:p>","DOI":"10.1002\/elps.70040","type":"journal-article","created":{"date-parts":[[2025,9,24]],"date-time":"2025-09-24T06:51:41Z","timestamp":1758696701000},"page":"1651-1660","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A Simple and Affordable CZE\u2013UV Method for Quality Control of Insulin in Active Pharmaceutical Ingredient and Formulations Using Quadruple Polymer\u2010Coated Capillary"],"prefix":"10.1002","volume":"46","author":[{"given":"Hailekiros Gebretsadik","family":"Kidanemariam","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis KU Leuven\u2014University of Leuven  Leuven Belgium"},{"name":"Department of Pharmaceutical Analysis and Quality Assurance College of Health Sciences, School of Pharmacy Mekelle University  Mekelle Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erwin","family":"Adams","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis KU Leuven\u2014University of Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Van Schepdael","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis KU Leuven\u2014University of Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,9,23]]},"reference":[{"key":"e_1_2_10_2_1","volume-title":"Substandard and Falsified Medical Products [Internet]","author":"World Health Organization","year":"2024"},{"key":"e_1_2_10_3_1","unstructured":"World Health Organization A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products [Internet](World Health Organization 2020) accessed: 2025 Feb 18 https:\/\/www.who.int\/publications\/i\/item\/9789241513432."},{"key":"e_1_2_10_4_1","volume-title":"Endotext","author":"Weiss M.","year":"2014"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrendo.2017.39"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.2337\/diaspect.17.3.183"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2021.109118"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4614-5441-0_26"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.analchem.8b00015"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/1522-2683(20000601)21:10<1921::AID-ELPS1921>3.0.CO;2-Y"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.202100727"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1351\/pac200678111993"},{"key":"e_1_2_10_13_1","volume-title":"United States Pharmacopeia and National Formulary (USP 46\u2013NF 41) Rockville (MD): United States Pharmacopeial Convention 2023: 1\u20103"},{"key":"e_1_2_10_14_1","volume-title":"Insulin, Human. 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[Internet] \u201dLabster accessed 10 June 2025 https:\/\/theory.labster.com\/de\/insulin\u2010structure\/."},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2020.461344"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2023.464286"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2022.463351"},{"key":"e_1_2_10_19_1","first-page":"167","article-title":"Application of the Capillary Zone Electrophoresis (CZE) and Capillary Gel Electrophoresis (CGE) for the Separation of Human Insulin, Insulin Lispro and Their Degradation Products","volume":"75","author":"Pajaziti B.","year":"2020","journal-title":"Die Pharmazie"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10337-016-3180-3"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2008.11.008"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/elps.201500178"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2014.12.038"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trac.2017.02.013"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/elps.200305648"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/elps.200305720"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1080\/10826070701191029"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/1522-2683(200107)22:12<2565::AID-ELPS2565>3.0.CO;2-I"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2010.08.027"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1365\/s10337\u2010007\u20100509"},{"key":"e_1_2_10_31_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.Validation of Analytical Procedures Q2(R2)[Internet](International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 2023) https:\/\/database.ich.org\/sites\/default\/files\/ICH_Q2%28R2%29_Guideline2023_1130.pdf."},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9673(97)00530-X"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1088\/0960-1317\/14\/8\/008"}],"container-title":["ELECTROPHORESIS"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/elps.70040","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,3]],"date-time":"2025-12-03T07:12:47Z","timestamp":1764745967000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/elps.70040"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,23]]},"references-count":32,"journal-issue":{"issue":"23","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1002\/elps.70040"],"URL":"https:\/\/doi.org\/10.1002\/elps.70040","archive":["Portico"],"relation":{},"ISSN":["0173-0835","1522-2683"],"issn-type":[{"value":"0173-0835","type":"print"},{"value":"1522-2683","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,23]]},"assertion":[{"value":"2025-04-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-12","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-23","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}