{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T19:59:12Z","timestamp":1790884752533,"version":"4.1.0"},"reference-count":38,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:00:00Z","timestamp":1790726400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Eur J Mass Spectrom (Chichester)"],"abstract":"<jats:p>\n                    In the present study, an efficient reverse-phase high-performance liquid chromatography method was developed for the quantification of impurities of icatibant (IBT) injection in finished formulations. The stationary phase employed is Kromasil 100 C18 with dimension of (150\u2009\u00d7\u20094.6) mm, 3.5\u2005\u00b5m. A 0.05\u2005M KH\n                    <jats:sub>2<\/jats:sub>\n                    PO\n                    <jats:sub>4<\/jats:sub>\n                    (pH 2.5) and methanol in the ratio of (90:10%v\/v) was used as eluent A and 0.05\u2005M KH\n                    <jats:sub>2<\/jats:sub>\n                    PO\n                    <jats:sub>4<\/jats:sub>\n                    (pH 2.5) and methanol in the ratio of\n                    <jats:italic toggle=\"yes\">(70:30%v\/v)<\/jats:italic>\n                    was used as eluent B pumped through 1.0\u2005mL\/min flow rate using photodiode array detector at 210\u2005nm. The IBT injection was analyzed under various degradation conditions, including acid, base, peroxide, photolytic, and thermal, were evaluated using a present proposed developed method. The method validation was carried out based on International Conference on Harmonization guidelines, by evaluating several key parameters. The observed limit of detection values were 0.066, 0.165, 0.165, 0.197, 0.134, and 0.493 \u03bcg\/mL, the observed limit of quantification values were 0.201, 0.501, 0.500, 0.598, 0.406, and 1.495 \u03bcg\/mL for icatibant (7\u201310), Des-Pro-Impurity, Des-Arg-impurity, Des-D-Arg-impurity, D-Tic (O) 8\u201310 icatibant and icatibant (1\u20136), respectively. The average recovery percentages of impurities of IBT injection were found to be 87.4% to 108.2%. The established methodology demonstrated linearity across a concentration interval of 0.020 to 34.73\u03bcg\/mL for IBT and its impurities. Specific unidentified \u201c\n                    <jats:italic toggle=\"yes\">Impurity at RRT about 0.92<\/jats:italic>\n                    \u201d (D-Tic (O) 8\u201310 Icatibant), \u201c\n                    <jats:italic toggle=\"yes\">Impurity at RRT about 1.15<\/jats:italic>\n                    ,\u201d \u201c\n                    <jats:italic toggle=\"yes\">Impurity at RRT about 1.24<\/jats:italic>\n                    ,\u201d and \u201c\n                    <jats:italic toggle=\"yes\">Impurity at RRT about 0.57<\/jats:italic>\n                    \u201d were identified and liquid chromatography-high resolution mass spectrometry technique was used for their characterization. This method was assessed and confirmed to be more reliable for quantifying impurities of IBT injections.\n                  <\/jats:p>","DOI":"10.1177\/14690667261489100","type":"journal-article","created":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T13:15:27Z","timestamp":1790774127000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Development and validation of an RP-HPLC method for the quantification of impurities of icatibant injection in finished formulations-identification and characterization of its impurities via LC-HRMS"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-2232-2872","authenticated-orcid":false,"given":"Sivaji","family":"Maganti","sequence":"first","affiliation":[{"name":"GITAM Deemed to be University"},{"name":"Eugia Pharma Research Centre, Sangareddy (Dist.), Telangana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suryakala","family":"Duvvuri","sequence":"additional","affiliation":[{"name":"GITAM Deemed to be University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ameer Khan","family":"Shaik","sequence":"additional","affiliation":[{"name":"Eugia Pharma Research Centre, Sangareddy (Dist.), Telangana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hari Satyanarayana","family":"Raju Danthuluri","sequence":"additional","affiliation":[{"name":"Eugia Pharma Research Centre, Sangareddy (Dist.), Telangana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simhachalam","family":"Pydi","sequence":"additional","affiliation":[{"name":"Eugia Pharma Research Centre, Sangareddy (Dist.), Telangana, India"},{"name":"Department of Chemistry, JNTU Hyderabad, University College of Engineering, Science, and Technology, Kukatpally, Telangana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,9,30]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1768"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.2147\/BTT.S27566"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1186\/s40413-017-0180-1"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2020.106304"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12016-021-08842-9"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1080\/17512433.2016.1182425"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1R423"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1097\/SHK.0b013e3182336a34"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.1991.tb12248.x"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.1991.tb12249.x"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.138"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.anai.2011.08.015"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1111\/cei.12358"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2019.03.003"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10989-016-9534-8"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2014.10.003"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.3390\/ijms20102383"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.6001"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.70129"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2023.106682"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11094-022-02610-5"},{"key":"e_1_3_4_23_2","first-page":"15700232","article-title":"Development of a novel HPLC-HRMS method for quantitative analysis of resorcinol in urine: application to hairdressers\u2019 occupational exposure","volume":"124472","author":"Amandine C. 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