{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T14:20:58Z","timestamp":1780496458718,"version":"3.54.1"},"reference-count":24,"publisher":"Wiley","issue":"23","license":[{"start":{"date-parts":[[2025,8,24]],"date-time":"2025-08-24T00:00:00Z","timestamp":1755993600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Rapid Comm Mass Spectrometry"],"published-print":{"date-parts":[[2025,12,15]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>Nitrosamine impurities, such as N\u2010nitroso diethylamine (NDEA), N\u2010nitroso dimethylamine (NDMA), and 1\u2010nitroso piperazine (1\u2010NP), have raised serious health concerns due to their carcinogenic and mutagenic properties. The pharmaceutical industry faces increasing regulatory pressure to monitor these compounds at trace levels. This study addresses the need for a robust analytical method to ensure the safety of lurasidone hydrochloride (LUR), an antipsychotic drug.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A sensitive and specific LC\u2013MS\/MS method was developed using atmospheric pressure chemical ionization (APCI) in positive mode and operated in multiple reaction monitoring (MRM). Chromatographic separation was performed on a Sapphirus C18 HP\u2010classic column under gradient elution, with 0.1% formic acid in water and methanol as the mobile phase. Detection was carried out using an Agilent 6470B triple\u2010quadrupole mass spectrometer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The method demonstrated excellent linearity (regression coefficient &gt;\u20090.999) across a range extending to 200% of the specified limit. Limits of detection and quantitation were suitable for trace\u2010level analysis. Accuracy was confirmed through recovery studies, with results ranging between 80 and 120%. The method met ICH Q2 (R2) validation criteria, ensuring reliability for regulatory use.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The developed APCI\u2010LC\u2013MS\/MS method provides accurate and reproducible quantification of NDEA, NDMA, and 1\u2010NP in lurasidone hydrochloride. Its sensitivity and compliance with regulatory standards make it suitable for routine quality control and stability testing of nitrosamine impurities in lurasidone hydrochloride drug substance.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/rcm.10126","type":"journal-article","created":{"date-parts":[[2025,8,25]],"date-time":"2025-08-25T06:35:12Z","timestamp":1756103712000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Assessment of Nitrosamine Impurities in Lurasidone Hydrochloride Using APCI\u2010LC\u2013MS\/MS in MRM Mode for Regulatory Compliance and Stability Evaluation"],"prefix":"10.1002","volume":"39","author":[{"given":"Anant\u00a0D.","family":"Yadav","sequence":"first","affiliation":[{"name":"Tarsadia Institute of Chemical Science Uka Tarsadia University  Bardoli Gujarat India"},{"name":"Analytical Research and Development, Alkem Laboratories Ltd.  Bharuch Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish\u00a0C.","family":"Alaspure","sequence":"additional","affiliation":[{"name":"Maliba Pharmacy College Uka Tarsadia University, Maliba Campus  Bardoli Gujarat India"},{"name":"Analytical Research and Development, Alkem Laboratories Ltd.  Bharuch Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pinal\u00a0S.","family":"Bhavsar","sequence":"additional","affiliation":[{"name":"Tarsadia Institute of Chemical Science Uka Tarsadia University  Bardoli Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandesh\u00a0R.","family":"Lodha","sequence":"additional","affiliation":[{"name":"Maliba Pharmacy College Uka Tarsadia University, Maliba Campus  Bardoli Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8324-2125","authenticated-orcid":false,"given":"Anil\u00a0H.","family":"Gore","sequence":"additional","affiliation":[{"name":"Tarsadia Institute of Chemical Science Uka Tarsadia University  Bardoli Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,24]]},"reference":[{"key":"e_1_2_11_2_1","volume-title":"StatPearls [Internet]. 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