{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T03:39:59Z","timestamp":1788406799664,"version":"build-2803163510"},"reference-count":32,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2022,5,6]],"date-time":"2022-05-06T00:00:00Z","timestamp":1651795200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"J\u00e1nos Bolyai Research Scholarship of the Hungarian Academy of Sciences","award":["EFOP-3.6.3-VEKOP-16-2017-00009"],"award-info":[{"award-number":["EFOP-3.6.3-VEKOP-16-2017-00009"]}]},{"name":"J\u00e1nos Bolyai Research Scholarship of the Hungarian Academy of Sciences","award":["511\/3\/17.01.2022"],"award-info":[{"award-number":["511\/3\/17.01.2022"]}]},{"name":"J\u00e1nos Bolyai Research Scholarship of the Hungarian Academy of Sciences","award":["10127\/3\/17.12.2020"],"award-info":[{"award-number":["10127\/3\/17.12.2020"]}]},{"name":"University of Medicine, Pharmacy, Science and Technology \u201cGeorge Emil Palade\u201d of Targu Mures","award":["EFOP-3.6.3-VEKOP-16-2017-00009"],"award-info":[{"award-number":["EFOP-3.6.3-VEKOP-16-2017-00009"]}]},{"name":"University of Medicine, Pharmacy, Science and Technology \u201cGeorge Emil Palade\u201d of Targu Mures","award":["511\/3\/17.01.2022"],"award-info":[{"award-number":["511\/3\/17.01.2022"]}]},{"name":"University of Medicine, Pharmacy, Science and Technology \u201cGeorge Emil Palade\u201d of Targu Mures","award":["10127\/3\/17.12.2020"],"award-info":[{"award-number":["10127\/3\/17.12.2020"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecules"],"abstract":"<jats:p>A novel, validated, reversed-phase (RP), chiral high performance liquid chromatography (HPLC) method was developed for the enantiopurity control analysis of naproxen, a frequently used non-steroidal anti-inflammatory agent using polysaccharide-type chiral stationary phase (CSP). In the screening phase of method development, seven columns were tested in polar organic (PO) mode using mobile phases consisting of 0.1% acetic acid in methanol, ethanol, 2-propanol, and acetonitrile. Enantiorecognition was observed only in five cases. The best enantioseparation was observed on a Lux Amylose-1 column with 0.1% (v\/v) acetic acid in ethanol with a resolution (Rs) of 1.24. The enantiomer elution order was unfavorable, as the distomer eluted after the eutomer. When the ethanolic mobile phase was supplemented with water, enantiomer elution order reversal was observed, indicating a difference in the enantiorecognition mechanism upon switching from PO to RP mode. Furthermore, by changing ethanol to methanol, not only lower backpressure, but also higher resolution was obtained. Subsequent method optimization was performed using a face-centered central composite design (FCCD) to achieve higher chiral resolution in a shorter analysis time. Optimized parameters offering baseline separation were as follows: Lux Amylose-1 stationary phase, thermostated at 40 \u00b0C, and a mobile phase consisting of methanol:water:acetic acid 85:15:0.1 (v\/v\/v), delivered with 0.65 mL\/min flow rate. Using these optimized parameters, a Rs = 3.21 \u00b1 0.03 was achieved within seven minutes. The optimized method was validated according to the ICH guidelines and successfully applied for the analysis of different pharmaceutical preparations, such as film-coated tablets and gel, as well as fixed-dose combination tablets, containing both naproxen and esomeprazole.<\/jats:p>","DOI":"10.3390\/molecules27092986","type":"journal-article","created":{"date-parts":[[2022,5,8]],"date-time":"2022-05-08T21:31:20Z","timestamp":1652045480000},"page":"2986","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Determination of Chiral Impurity of Naproxen in Different Pharmaceutical Formulations Using Polysaccharide-Based Stationary Phases in Reversed-Phased Mode"],"prefix":"10.3390","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5633-0530","authenticated-orcid":false,"given":"Lajos-Attila","family":"Papp","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical and Therapeutic Chemistry, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540142 Targu Mures, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarolta","family":"Krizbai","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical and Therapeutic Chemistry, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540142 Targu Mures, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M\u00e1t\u00e9","family":"Dob\u00f3","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry, Semmelweis University, 1092 Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2564-9271","authenticated-orcid":false,"given":"Gabriel","family":"Hancu","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical and Therapeutic Chemistry, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540142 Targu Mures, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8740-0212","authenticated-orcid":false,"given":"Zolt\u00e1n-Istv\u00e1n","family":"Szab\u00f3","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Industry and Management, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 540142 Targu Mures, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5341-319X","authenticated-orcid":false,"given":"Gerg\u0151","family":"T\u00f3th","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry, Semmelweis University, 1092 Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,5,6]]},"reference":[{"key":"ref_1","first-page":"1","article-title":"In vivo study of light-driven naproxen release from gated mesoporous silica drug delivery system","volume":"11","author":"Lisnichuk","year":"2021","journal-title":"Sci. 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