{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,11]],"date-time":"2026-04-11T23:26:23Z","timestamp":1775949983261,"version":"3.50.1"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2021,6,12]],"date-time":"2021-06-12T00:00:00Z","timestamp":1623456000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,3,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Non-depolarizing neuromuscular blocking agent Rocuronium bromide was quantified in drug substance and drug product using reversed-phase liquid chromatographic method. Forced degradation studies were conducted for Rocuronium bromide in drug substance under acidic (2MHCl), basic (2MNaOH), oxidative (3% H2O2), thermal (135\u00b0C) and photolytic (254 nm) stress conditions. An Agilent H12 C18 column was used for separation using diammonium hydrogen phosphate buffer (pH 8; 0.04M)- acetonitrile (50:50; v\/v) as mobile phase at flow rate of 1 mL\/min. The quantification was done using UV detection at 210 nm. The limit of quantification and detection was 11.1 and 3.66 \u03bcg\/mL, respectively, and the recovery percentage was 99% in drug substance and drug product. ICH guidelines were adopted for method validation. The proposed LC method monitored the degradation profile for Rocuronium bromide under various stress conditions and provided a specific LC method for its routine analysis. Besides, the MS data were used to identify all Rocuronium bromide degradation products and the possible degradation pathway was designated.<\/jats:p>","DOI":"10.1093\/chromsci\/bmab065","type":"journal-article","created":{"date-parts":[[2021,6,8]],"date-time":"2021-06-08T11:45:34Z","timestamp":1623152734000},"page":"217-223","source":"Crossref","is-referenced-by-count":4,"title":["Application of ICH Guidelines for Studying the Degradation Behavior of Rocuronium Bromide Coupled with Stability-Indicating RP-LC Method"],"prefix":"10.1093","volume":"60","author":[{"given":"Ola M","family":"El Houssini","sequence":"first","affiliation":[{"name":"National Organization for Drug Control and Research (NODCAR), 51 wezaret El- Zeraa Street, Agouza, Giza 35521, Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohamed K","family":"Abd El-Rahman","sequence":"additional","affiliation":[{"name":"Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo 11562, Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diana K","family":"Fahem","sequence":"additional","affiliation":[{"name":"National Organization for Drug Control and Research (NODCAR), 51 wezaret El- Zeraa Street, Agouza, Giza 35521, Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hala E","family":"Zaazaa","sequence":"additional","affiliation":[{"name":"Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo 11562, Egypt"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2021,6,12]]},"reference":[{"key":"2022032516091634000_ref1","first-page":"2036","volume-title":"Martindale: The Complete Drug Reference","author":"Sweetman","year":"2014","edition":"38th"},{"key":"2022032516091634000_ref2","first-page":"1423","volume-title":"The Merch 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