{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,6]],"date-time":"2026-04-06T17:20:39Z","timestamp":1775496039646,"version":"3.50.1"},"reference-count":14,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,6,9]],"date-time":"2025-06-09T00:00:00Z","timestamp":1749427200000},"content-version":"vor","delay-in-days":8,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Separation Science"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    New chiral isocratic HPLC conditions were proposed for investigation of moxifloxacin hydrochloride and its potential isomeric impurity (R,R)\u2010isomer (impurity G) using the chiral additive copper (II)\u2010sulfate and isoleucine in the mobile phase using an achiral C18 chromatographic column, 150 \u00d7 4.6\u00a0mm; 3\u00a0\u00b5m, as a significant improvement of the official European Pharmacopeia method concerning economy and baseline resolution. The mechanism of separation of enantiomers of moxifloxacin using the chiral additive copper (II)\u2010sulfate is also elucidated. In the optimization of the experimental conditions of the chiral HPLC method, the central composite design was used, and for multiobjective optimization the desirability function with its desired value 1.00 was used. After optimization and method validation the best conditions concerning the concentration of chiral agents (0.01\u00a0M), organic solvent content in the mobile phase (30%, v\/v methanol), pH value of mobile phase (3.5), and column temperature (23\u00b0C) with 10\u00a0\u00b5L injection volume, were defined. Compared to the pharmacopeial HPLC method, the analysis time was shorter and significantly lower amount of chiral agents in mobile phase was required. The optimized method was validated with respect to linearity, accuracy, precision, and robustness. The linearity of the method has been demonstrated in the range of 0.30\u20132.50\u00a0\u00b5g\/mL (\n                    <jats:italic>R<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    &gt; 0.998). Limit of detection and limit of quantification for moxifloxacin chiral impurity G determination were 0.098 and 0.298\u00a0\u00b5g\/mL, respectively. The method was found to be suitable for quantification of moxifloxacin chiral impurity G in moxifloxacin drug substance.\n                  <\/jats:p>","DOI":"10.1002\/jssc.70190","type":"journal-article","created":{"date-parts":[[2025,6,9]],"date-time":"2025-06-09T03:49:59Z","timestamp":1749440999000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Improvement of Pharmacopeial High\u2010Performance Liquid Chromatography Method for Determination of Enantiomeric Purity of Moxifloxacin Drug Substance"],"prefix":"10.1002","volume":"48","author":[{"given":"Alma","family":"Salki\u0107","sequence":"first","affiliation":[{"name":"ZADA Pharmaceuticals d.o.o.  Lukavac Bosnia and Herzegovina"},{"name":"Department of Drug Analysis Faculty of Pharmacy University of Tuzla  Tuzla Bosnia and Herzegovina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Biljana","family":"Ota\u0161evi\u0107","sequence":"additional","affiliation":[{"name":"Department of Drug Analysis Faculty of Pharmacy University of Belgrade  Belgrade Serbia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mira","family":"Ze\u010devi\u0107","sequence":"additional","affiliation":[{"name":"Department of Drug Analysis Faculty of Pharmacy University of Belgrade  Belgrade Serbia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,6,9]]},"reference":[{"key":"e_1_2_6_2_1","first-page":"3452","volume-title":"European Pharmacopoeia (Ph. Eur.)","author":"EDQM","year":"2023"},{"key":"e_1_2_6_3_1","unstructured":"The United States Pharmacopoeia National formulary. USP45\u2010NF40(United States Pharmacopoeial Convention 2022)."},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.202300604"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.70132"},{"issue":"2","key":"e_1_2_6_6_1","first-page":"88","article-title":"Chiral Separation and Determination of Enantiomeric Purity of the Pharmaceutical Formulation of Cefadroxil Using Coated and Immobilized Amylose\u2010Derived and Cellulose\u2010Derived Chiral Stationary Phases","volume":"15","author":"Mohammed N. R.","year":"2018","journal-title":"Egyptian Pharmaceutical Journal"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.202200209"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.70150"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.202300145"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.70045"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2023.115645"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2004.12.004"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1365\/s10337-008-0853-6"},{"key":"e_1_2_6_14_1","unstructured":"ICH Q2 (R1); Validation of Analitical Procedures: Text and Metodology The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 1\u201317."},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.3390\/molecules23051065"}],"container-title":["Journal of Separation Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jssc.70190","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T08:42:46Z","timestamp":1764664966000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/jssc.70190"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6]]},"references-count":14,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1002\/jssc.70190"],"URL":"https:\/\/doi.org\/10.1002\/jssc.70190","archive":["Portico"],"relation":{},"ISSN":["1615-9306","1615-9314"],"issn-type":[{"value":"1615-9306","type":"print"},{"value":"1615-9314","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6]]},"assertion":[{"value":"2025-01-31","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-19","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-09","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70190"}}