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The study developed a simple, economical but highly sensitive procedure for the simultaneous quantification of seven nitrosamines and AZBT impurities in sartan pharmaceuticals. After extraction with methanol (MeOH) 50%, the compounds were analyzed with a reversed\u2010phase liquid chromatography\u2013tandem mass spectroscopy with atmospheric\u2010pressure chemical ionization (APCI) mode (APCI[+] for nitrosamines and APCI[\u2212] for AZBT), selected reaction monitoring, C18 column, gradient elution with 0.1% formic acid in water and in MeOH, respectively. The validated procedure obtained high extraction efficiency (&gt;90%), wide linear range (0.2\u201350.0\u00a0ng\/mL NMBA, NDEA, NDIPA, NMPA, and NDBA; 0.5\u201350.0\u00a0ng\/mL NDMA and NEIPA; 2.0\u2013100\u00a0ng\/mL AZBT), limit of quantification &lt;\u00a010% of the acceptance level, recovery range of 85%\u2013115% with relative standard deviation &lt;\u00a015% and minimum matrix effects for all impurities. The procedure was applied to test 16 commercial losartan samples. As a result, eight samples contained AZBT within the current regulatory limits, but no nitrosamine impurities were detected in all samples.<\/jats:p>","DOI":"10.1002\/jssc.202400277","type":"journal-article","created":{"date-parts":[[2024,10,10]],"date-time":"2024-10-10T09:28:36Z","timestamp":1728552516000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["High\u2010Performance Liquid Chromatography\u2013Tandem Mass Spectrometry Method Development and Validation for Simultaneous Determination of Seven Nitrosamine and Azidomethyl\u2010Biphenyl\u2010Tetrazole Impurities in Losartan"],"prefix":"10.1002","volume":"47","author":[{"given":"Nguyen Minh","family":"Luan","sequence":"first","affiliation":[{"name":"Department of Analytical Chemistry and Drug Quality Control Faculty of Pharmacy University of Medicine and Pharmacy at Ho Chi Minh City  Vietnam"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4359-9335","authenticated-orcid":false,"given":"Vo Thi Kim","family":"Khuyen","sequence":"additional","affiliation":[{"name":"Department of Analytical Chemistry and Drug Quality Control Faculty of Pharmacy University of Medicine and Pharmacy at Ho Chi Minh City  Vietnam"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nguyen Duc","family":"Tuan","sequence":"additional","affiliation":[{"name":"Department of Analytical Chemistry and Drug Quality Control Faculty of Pharmacy University of Medicine and Pharmacy at Ho Chi Minh City  Vietnam"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,10,9]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.1956.15"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.5530\/ijopp.13.1.1"},{"key":"e_1_2_9_4_1","unstructured":"US FDA \u201cFDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan Losartan and Irbesartan) \u201d Accessed September 21 2023 https:\/\/www.fda.gov\/drugs\/drug\u2010safety\u2010and\u2010availability\/fda\u2010updates\u2010and\u2010press\u2010announcements\u2010angiotensin\u2010ii\u2010receptor\u2010blocker\u2010arb\u2010recalls\u2010valsartan\u2010losartan."},{"key":"e_1_2_9_5_1","unstructured":"European Medicine Agency \u201cEMA\/369136\/2020 Committee for Medicinal Products for Human Use (CHMP) Procedure under Article 5(3) of Regulation EC (No) 726\/2004: Nitrosamine impurities in human medicinal products \u201d2020."},{"key":"e_1_2_9_6_1","unstructured":"ICH Harmonized Guideline \u201cAssessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. 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