{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T05:27:59Z","timestamp":1773898079388,"version":"3.50.1"},"reference-count":27,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,7,21]],"date-time":"2024-07-21T00:00:00Z","timestamp":1721520000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Chirality"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>In order to improve and replace the enantiomer method outlined in the olodaterol hydrochloride draft monograph (From the European Pharmacopoeia forum), one new, simple, and fast enantioselective normal phase high\u2010performance liquid chromatography chiral method was developed on polysaccharide\u2010based Chiral MX (2) (4.6\u2009\u00d7\u2009250\u2009mm, 5\u2009\u03bcm) column. n\u2010Hexane, ethanol, and diethylamine in the ratio of 40:60:0.1 (V\/V\/V) were selected as mobile phase at a flow rate of 0.8\u2009mL\/min, and the detection was performed on a photodiode array detector at 225\u2009nm with 5\u2009\u03bcL injection volume. The column temperature was set at 40\u00b0C for better peak shape and sensitivity. The analysis time can be shortened to 15\u2009min, whereas the resolution between enantiomer and olodaterol was found to be even more than 10.0, which was far better than that obtained with the reported method in this draft monograph. The developed chiral method was validated in accordance with ICH Q2 (R1), including specificity, LOD&amp;LOQ, precision, linearity, accuracy, and robustness. Thereby, the proposed method was demonstrated to be suitable for the determination of enantiomer in\u00a0olodaterol hydrochloride bulk drug and drug product. Besides, the thermodynamic parameters were evaluated on the basis of Van't Hoff plots that was used to explain correlative chiral recognition mechanisms with the chiral stationary phase.<\/jats:p>","DOI":"10.1002\/chir.23704","type":"journal-article","created":{"date-parts":[[2024,7,22]],"date-time":"2024-07-22T02:45:00Z","timestamp":1721616300000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["The Development of One New Normal Phase Liquid Chromatography Method and Thermodynamic Investigation of Olodaterol Hydrochloride Enantiomer"],"prefix":"10.1002","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-2869-7612","authenticated-orcid":false,"given":"Wanbing","family":"Rao","sequence":"first","affiliation":[{"name":"HEC Research and Development Center HEC Pharm Group  Dongguan China"},{"name":"State Key Laboratory of Anti\u2010Infective Drug Development Sunshine Lake Pharma Co., Ltd  Dongguan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chenxia","family":"Zhang","sequence":"additional","affiliation":[{"name":"HEC Research and Development Center HEC Pharm Group  Dongguan China"},{"name":"State Key Laboratory of Anti\u2010Infective Drug Development Sunshine Lake Pharma Co., Ltd  Dongguan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Baolei","family":"Luan","sequence":"additional","affiliation":[{"name":"HEC Research and Development Center HEC Pharm Group  Dongguan China"},{"name":"State Key Laboratory of Anti\u2010Infective Drug Development Sunshine Lake Pharma Co., Ltd  Dongguan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhongqing","family":"Wang","sequence":"additional","affiliation":[{"name":"HEC Research and Development Center HEC Pharm Group  Dongguan China"},{"name":"State Key Laboratory of Anti\u2010Infective Drug Development Sunshine Lake Pharma Co., Ltd  Dongguan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meiyan","family":"Qiu","sequence":"additional","affiliation":[{"name":"HEC Research and Development Center HEC Pharm Group  Dongguan China"},{"name":"State Key Laboratory of Anti\u2010Infective Drug Development Sunshine Lake Pharma Co., Ltd  Dongguan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-3795-4692","authenticated-orcid":false,"given":"Shaoyu","family":"Cai","sequence":"additional","affiliation":[{"name":"HEC Research and Development Center HEC Pharm Group  Dongguan China"},{"name":"State Key Laboratory of Anti\u2010Infective Drug Development Sunshine Lake Pharma Co., Ltd  Dongguan China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,7,21]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2018.1518431"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/resp.13012"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1124\/pr.111.004580"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.111.179259"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265\u2010019\u201001133\u2010w"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pupt.2011.07.006"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2005.02.037"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2010.07.005"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2023.115641"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2014.11.027"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2014.06.011"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2021.114467"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2021.114039"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/chir.23600"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/chir.22150"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10337\u2010018\u20103526\u20100"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/chromsci\/30.3.67"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trac.2019.115709"},{"key":"e_1_2_7_20_1","unstructured":"\u201cOlodaterol Hydrochloride Draft Monograph. 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