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To support a widespread therapeutic drug monitoring of isavuconazole, a simple, sensitive, and precise high\u2010performance liquid chromatography method with UV detection was developed and fully validated for the quantification of this drug in human plasma. The method involved a combined protein precipitation\u2212solid\u2010phase extraction and a chromatographic separation on a Waters XTerra RP<jats:sub>18<\/jats:sub> (150\u2009\u00d7\u20094.6\u2009mm, 3.5 \u03bcm) column using an isocratic mobile phase of ammonium acetate buffer (pH\u20098.0, 10\u2009m<jats:sc>m<\/jats:sc>) and acetonitrile (45:55, v\/v). The UV detection was performed at 285\u2009nm. This method was linear (correlation coefficients \u22650.998), specific (no interference with plasma components or various potentially co\u2010administrated drugs), sensitive (lower limit of quantification of 0.025 \u03bcg\/mL), reproducible (coefficients of variation were \u22647.9%) and accurate (deviations ranged from \u22125.0 to 8.0%) over the range of 0.025\u201310\u2009\u03bcg\/mL. The method fulfilled all of the US Food and Drug Administration guidelines validation criteria and performed well in an international proficiency testing program. The assay was also successfully applied to routine therapeutic drug monitoring of patients and to drug stability investigations under various conditions.<\/jats:p>","DOI":"10.1002\/bmc.4333","type":"journal-article","created":{"date-parts":[[2018,7,6]],"date-time":"2018-07-06T06:08:12Z","timestamp":1530857292000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["A sensitive and validated HPLC\u2010UV method for the quantitative determination of the new antifungal drug isavuconazole in human plasma"],"prefix":"10.1002","volume":"32","author":[{"given":"Giulio","family":"Nannetti","sequence":"first","affiliation":[{"name":"Department of Molecular Medicine University of Padua  Padua Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvana","family":"Pagni","sequence":"additional","affiliation":[{"name":"Department of Molecular Medicine University of Padua  Padua Italy"},{"name":"Clinical Microbiology and Virology Unit Padua University Hospital  Padua Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giorgio","family":"Pal\u00f9","sequence":"additional","affiliation":[{"name":"Department of Molecular Medicine University of Padua  Padua Italy"},{"name":"Clinical Microbiology and Virology Unit Padua University Hospital  Padua Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8900-861X","authenticated-orcid":false,"given":"Arianna","family":"Loregian","sequence":"additional","affiliation":[{"name":"Department of Molecular Medicine University of Padua  Padua Italy"},{"name":"Clinical Microbiology and Virology Unit Padua University Hospital  Padua Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,9,11]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"Astellas Pharma US. 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