{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T20:56:11Z","timestamp":1785012971914,"version":"3.55.0"},"reference-count":33,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T00:00:00Z","timestamp":1708560000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100001843","name":"Science and Engineering Research Board","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001843","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In the pharmaceutical industry, effective risk management and control strategies for potential genotoxic impurities are of paramount importance. The current study utilized GC\u2013MS to evaluate a precise, linear, and accurate analytical method for quantifying ethylenediamine present in tripelennamine hydrochloride using phthalaldehyde as a derivatizing agent. When phthalaldehyde is sonicated for 10 min at room temperature, it reacts with ethylenediamine to form (1z,5z)\u20103,4\u2010dihydrobenzo[f][1,4]diazocine. This approach minimizes matrix interference issues and resolves sample preparation difficulties encountered during ethylenediamine identification in GC\u2013MS. In this method, helium serves as the carrier gas, while methanol acts as the diluent. The stationary phase consists of a DB\u20105MS column (30 m \u00d7 0.25 mm \u00d7 0.25 \u03bcm) with a flow rate of 1.5 mL\/min. The retention time of (1z,5z)\u20103,4\u2010dihydrobenzo[f][1,4]diazocine was determined to be 6.215 min. The method validation demonstrated limits of detection and quantification for (1z,5z)\u20103,4\u2010dihydrobenzo[f][1,4]diazocine at 0.4 and 1.0 ppm, respectively, with a linearity range spanning from 1 to 30 ppm concentration with respect to the specification level. System suitability, precision, linearity, and accuracy of the current method were assessed in accordance with guidelines, yielding results deemed suitable for the intended use.<\/jats:p>","DOI":"10.1002\/bmc.5850","type":"journal-article","created":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T19:04:05Z","timestamp":1708628645000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Analytical determination of ethylenediamine impurity in tripelennamine hydrochloride by gas chromatography\u2013mass spectrometry using phthalaldehyde as the derivatizing agent"],"prefix":"10.1002","volume":"38","author":[{"given":"Sayyad","family":"Kousrali","sequence":"first","affiliation":[{"name":"Department of Engineering Chemistry, Koneru Lakshmaiah Education Foundation, Aziznagar  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leela Prasad","family":"Kowtharapu","sequence":"additional","affiliation":[{"name":"Analytical Development Department, Shenzhen DEC Pharmaceutical Co., Ltd  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3060-795X","authenticated-orcid":false,"given":"Tanmoy","family":"Mondal","sequence":"additional","affiliation":[{"name":"Department of Engineering Chemistry, Koneru Lakshmaiah Education Foundation, Aziznagar  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,2,22]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"065","article-title":"A sensitive, stability indicating UPLC method for the identification and characterization of forced degradation products for drometrizole trisiloxane through MSn studies","volume":"8","author":"Babu M. 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