{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T01:55:02Z","timestamp":1760061302707,"version":"build-2065373602"},"reference-count":14,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2019,3,18]],"date-time":"2019-03-18T00:00:00Z","timestamp":1552867200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100004909","name":"Universidade Federal do Rio Grande do Sul","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004909","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":[[2019,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Radiopharmaceuticals are radioactive compounds that can be used for diagnostic and therapeutic purposes. Technetium (99mTc) Sestamibi is the most commercialized radiopharmaceutical in the world. It includes a coordination complex consisting of the radioisotope 99\u2009m technetium bound to six copper tetramibi tetrafluorborate ligands, and is mainly used to image the myocardium via scintigraphy. As radiopharmaceuticals are regarded as drugs, they are subject to the same regulations; therefore, the objective of this study was to develop a quantification method for the active pharmaceutical ingredient before their complexation with the radioisotope by employing high\u2010performance liquid chromatography (HPLC) methodology. A simple and efficient method (retention time\u2009=\u20092.5\u2009min) was developed and validated for copper tetramibi tetrafluorborate in the final product using a buffer and organic solvent mixtures (ACN\u2013methanol\u2013ammonium sulfate buffer) and a C<jats:sub>18<\/jats:sub> column. The analytical protocol was fast, taking around 30\u2009min until evaluation of results. The validation parameters were evaluated with satisfactory results: in terms of linearity <jats:italic>r<\/jats:italic>\u2009&gt;\u20090.99 (160\u2013240\u2009\u03bcg\/mL) and no deviation was observed. The RSD of precision was &lt;5%, and an average recovery of 99% was observed for accuracy. The proposed method was thus considered adequate for routine analysis in the pharmaceutical industries.<\/jats:p>","DOI":"10.1002\/bmc.4490","type":"journal-article","created":{"date-parts":[[2019,1,16]],"date-time":"2019-01-16T22:36:24Z","timestamp":1547678184000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development of a rapid HPLC method for quantification of the copper tetramibi tetraflourborate in a kit for preparation of Technetium 99 m Sestamibi Injection"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2059-2395","authenticated-orcid":false,"given":"Fernanda Gobbi","family":"de Bitencourt","sequence":"first","affiliation":[{"name":"Programa de P\u00f3s\u2010Gradua\u00e7\u00e3o em Ci\u00eancias Farmac\u00eauticas Universidade Federal do Rio Grande do Sul (UFRGS)  Porto Alegre Rio Grande do Sul Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guilherme Oliveira","family":"Petersen","sequence":"additional","affiliation":[{"name":"Faculdade de Farm\u00e1cia Pontif\u00edcia Universidade Cat\u00f3lica do Rio Grande do Sul (PUCRS)  Porto Alegre Rio Grande do Sul Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C\u00e1ssia Virginia","family":"Garcia","sequence":"additional","affiliation":[{"name":"Programa de P\u00f3s\u2010Gradua\u00e7\u00e3o em Ci\u00eancias Farmac\u00eauticas Universidade Federal do Rio Grande do Sul (UFRGS)  Porto Alegre Rio Grande do Sul Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,3,18]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"Brasil. Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria. (2017).Resolu\u00e7\u00e3o\u2014RDC N\u00b0 166 de 24 DE Julho De 2017. Guia para valida\u00e7\u00e3o de m\u00e9todos anal\u00edticos. Di\u00e1rio Oficial da Rep\u00fablica Federativa do Brasil Bras\u00edlia DF."},{"key":"e_1_2_6_3_1","unstructured":"Brasil. Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria. (2009).Resolu\u00e7\u00e3o \u2010 RDC N\u00b0 64 DE 18 De Dezembro de 2009. Estabelecer os requisitos m\u00ednimos a serem observados na fabrica\u00e7\u00e3o de radiof\u00e1rmacos que deve cumprir com as Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o de Radiof\u00e1rmacos e de Medicamentos. Di\u00e1rio Oficial da Rep\u00fablica Federativa do Brasil Bras\u00edlia DF."},{"key":"e_1_2_6_4_1","unstructured":"Brasil. Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria. (2010).Resolu\u00e7\u00e3o\u2014RDC N\u00b0 17 DE 16 DE Abril De 2010. Estabelecer os requisitos m\u00ednimos a serem seguidos na fabrica\u00e7\u00e3o de medicamentos para padronizar a verifica\u00e7\u00e3o do cumprimento das Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o de Medicamentos (BPF) de uso humano durante as inspe\u00e7\u00f5es sanit\u00e1rias. Di\u00e1rio Oficial da Rep\u00fablica Federativa do Brasil Bras\u00edlia DF."},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1590\/S0066-782X2004001700008"},{"key":"e_1_2_6_6_1","unstructured":"European Pharmacopeia. (2017).9.0 Techetium (99mTc) Sestamibi injection."},{"key":"e_1_2_6_7_1","first-page":"68","article-title":"Calibra\u00e7\u00e3o: Uma revis\u00e3o para qu\u00edmicos anal\u00edticos","volume":"19","author":"Pimentel M. F.","year":"1996","journal-title":"Quimica Nova"},{"key":"e_1_2_6_8_1","unstructured":"Radiotra\u00e7adores. (2006).Arquivos Brasileiros de Cardiologia\u2014Volume 86 Suplemento I.http:\/\/www.scielo.br\/pdf\/abc\/v86s1\/a04v86s1.pdf"},{"key":"e_1_2_6_9_1","unstructured":"RPH\u2010MIBI. (2017).Retrieved December 15th 2017 fromhttp:\/\/www.gruporph.com.br\/www\/images\/bulas\/Bula_MIBI.pdf"},{"volume-title":"Fundamentals of nuclear pharmacy","year":"2003","author":"Saha G. B.","key":"e_1_2_6_10_1"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9673(02)01536-4"},{"key":"e_1_2_6_12_1","unstructured":"Silva S. K. &Silva S.(2005).S\u00edntese do composto Tetrafluorborato de cobre (I) tetracis (2\u2010metoxi isobutil isonitrila)\u2014Cu[MIBI4BF4]: substrato utilizado na produ\u00e7\u00e3o do radiof\u00e1rmaco SESTAMIBI\u201099m\u2010Tc Master's thesis). Universidade de S\u00e3o Paulo\/IPEN."},{"volume-title":"The United States pharmacopeia","year":"2015","author":"USP 38","key":"e_1_2_6_13_1"},{"key":"e_1_2_6_14_1","unstructured":"WHO. (2008).Radiopharmaceuticals\u2014Final text for addition to The International Pharmacopoeia November 2008. World Health Organization. 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