{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,2,8]],"date-time":"2024-02-08T00:22:03Z","timestamp":1707351723331},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2023,5,18]],"date-time":"2023-05-18T00:00:00Z","timestamp":1684368000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"New Time Pharmaceutical Co. LTD"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,2,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Elagolix sodium is a gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling by competitively binding to GnRH receptors in the pituitary gland to treat moderate to severe pain associated with endometriosis. To keep the safety and quality of the drug, a fast quantitative method by reversed-phase ultrahigh-performance liquid chromatography coupled with tandem mass spectrometry has been developed and validated for the identification, assay and estimation of potential genotoxic impurities trimethyl phosphate and triisopropyl phosphate in commercial batches of this active pharmaceutical ingredient in accordance with International Conference on Harmonization guidelines Q2 and M7. The method was validated by assessing specificity, sensitivity, linearity, the limit of quantification and detection, accuracy, precision and robustness for above analytes at a very low concentration, whose quantification and detection limits reached to 24 and 4.8\u00a0pg\/ml, respectively, and the total run time for a single injection was 6\u00a0min.<\/jats:p>","DOI":"10.1093\/chromsci\/bmad038","type":"journal-article","created":{"date-parts":[[2023,5,19]],"date-time":"2023-05-19T20:05:09Z","timestamp":1684526709000},"page":"140-146","source":"Crossref","is-referenced-by-count":0,"title":["UHPLC-MS\/MS Method Development and Validation for the Genotoxic Impurities Trimethyl Phosphate and Triisopropyl Phosphate of Elagolix Sodium"],"prefix":"10.1093","volume":"62","author":[{"given":"Yajie","family":"Hao","sequence":"first","affiliation":[{"name":"Department of International Pharmaceutical R&D Centre, Lunan Pharmaceutical Group , 1 North Outer Ring Road, Fei County, Linyi City, Shandong 273400 , China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhong","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of International Pharmaceutical R&D Centre, Lunan Pharmaceutical Group , 1 North Outer Ring Road, Fei County, Linyi City, Shandong 273400 , China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xuhui","family":"Zhuang","sequence":"additional","affiliation":[{"name":"Department of International Pharmaceutical R&D Centre, Lunan Pharmaceutical Group , 1 North Outer Ring Road, Fei County, Linyi City, Shandong 273400 , China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hao","family":"Teng","sequence":"additional","affiliation":[{"name":"Department of International Pharmaceutical R&D Centre, Lunan Pharmaceutical Group , 1 North Outer Ring Road, Fei County, Linyi City, Shandong 273400 , China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guimin","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of International Pharmaceutical R&D Centre, Lunan Pharmaceutical Group , 1 North Outer Ring Road, Fei County, Linyi City, Shandong 273400 , China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2023,5,18]]},"reference":[{"issue":"4","key":"2024020719271119200_ref1","doi-asserted-by":"crossref","first-page":"221","DOI":"10.1358\/dof.2013.38.4.1946380","article-title":"ELAGOLIX SODIUM gonadotropin-releasing hormone (GnRH) antagonist treatment of endometriosis[J]","volume":"38","author":"Peng","year":"2013","journal-title":"Drugs of the Future"},{"key":"2024020719271119200_ref2","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1358\/dot.2019.55.4.2930713","article-title":"Elagolix sodium for the treatment of women with moderate to severe endometriosis-associated pain. 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