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The separation was achieved on a Waters Acquity BEH Shield RP18 (100\u2009\u00d7\u00a02.1\u00a0mm, 1.7\u00a0\u03bcm) column in gradient elution mode with 0.1% formic acid and acetonitrile as the mobile phases and a flow rate of 0.5\u00a0mL\/min. For simultaneous quantification, the multiple reaction monitoring technique was utilized. The procedure was successfully validated in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The peak areas of both impurities, along with their concentrations, exhibited a good relationship with Pearson's correlation coefficient (<jats:italic>R<\/jats:italic>), which was &gt;0.999 in the range of 0.3\u20136\u00a0ppm with an EGZ concentration of 2\u00a0mg\/mL. The percentage recoveries from the limit of quantitation (LOQ) to 200% to the specification level were in the range of 94.82%\u2013102.92%, whereas the percentage relative standard deviation (%RSD) was &lt;2. Therefore, this method is rapid and accurate to quantify MMBS, EMBS, and EGZ assay simultaneously from the marketed tablet dosage forms of EGZ for commercial release and stability sample testing.<\/jats:p>","DOI":"10.1002\/bmc.5755","type":"journal-article","created":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T21:14:08Z","timestamp":1698700448000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["A sensitive ultra\u2010performance liquid chromatography\u2010tandem mass spectrometry method for the simultaneous quantification of assay and trace\u2010level genotoxic tosylate analogs (methyl and ethyl) in empagliflozin and its tablet dosage forms"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3827-9014","authenticated-orcid":false,"given":"Srinivas","family":"Nakka","sequence":"first","affiliation":[{"name":"Department of Chemistry, School of Science GITAM Deemed to be University  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1171-5189","authenticated-orcid":false,"given":"Siva Krishna","family":"Muchakayala","sequence":"additional","affiliation":[{"name":"Analytical Research and Development Catalent Pharma Solutions  Winchester Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9938-1242","authenticated-orcid":false,"given":"Surendra Babu","family":"Manabolu Surya","sequence":"additional","affiliation":[{"name":"Department of Chemistry, School of Science GITAM Deemed to be University  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,10,30]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2021.114078"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.202100136"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1039\/C5RA17231D"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/chromsci\/bmx030"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/22297928.2017.1404929"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehab798"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.122.059755"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2021.114001"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1358\/dot.2015.51.9.2368554"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.31777"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-018-0937-z"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2015.05.008"},{"key":"e_1_2_8_14_1","first-page":"1081","article-title":"Empagliflozin: HPLC based analytical method development and application to pharmaceutical raw material and dosage form","volume":"34","author":"Hanif A. 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