Reliable and Easy-To-Use Liquid Chromatography–Tandem Mass Spectrometry Method for Simultaneous Analysis of Fluconazole, Isavuconazole, Itraconazole, Hydroxy-Itraconazole, Posaconazole, and Voriconazole in Human Plasma and Serum

Müller, Carsten; Gehlen, David B.; Blaich, Cornelia; Prozeller, Domenik; Liss, Blasius; Streichert, Thomas; Wiesen, Martin H. J.

doi:10.1097/ftd.0000000000000438

Cited by 19 publications

(13 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As summarized in Table 3, ISC was found to be stable in human plasma under all tested stability conditions (one-way analysis of variance, not significant). Specifically, stability was confirmed for ISC in plasma samples stored at RT for 48 h and after three freeze-thaw cycles, as reported in previous studies (Farowski et al, 2010;Fatiguso et al, 2017;Jørgensen et al, 2017;Müller et al, 2017;Toussaint et al, 2017;Verweij-van Wissen et al, 2012). Stability of the analyte was also found in plasma stored at −80°C for 5 months, and when heated at 60°C for 60 min ( (Loregian et al, 2006: Loregian, Scarpa, Pagni, Parisi, & Palù, 2007.…”

Section: Stability Datasupporting

confidence: 80%

“…The stability of ISC was also investigated in plasma samples spiked with the drug at three different concentration levels and subjected to different storage and treatment conditions which clinical samples can commonly experience during the whole TDM process. Specifically, stability was confirmed for ISC in plasma samples stored at RT for 48 h and after three freeze-thaw cycles, as reported in previous studies (Farowski et al, 2010;Fatiguso et al, 2017;Jørgensen et al, 2017;Müller et al, 2017;Toussaint et al, 2017;Verweij-van Wissen et al, 2012). Each QC sample of both groups was assayed in triplicate.…”

Section: Stability Datamentioning

confidence: 78%

“…Waiting to define the precise role of TDM for ISC, the determination of drug exposure is already required in selected clinical cases to adjust the drug dosage, in order to guarantee the effectiveness of therapy and to minimize the toxicity (Stott & Hope, 2017). Previously published methods for the determination of ISC levels in plasma involved the use of UPLC, LC-MS/MS or fluorescence detectors, which are not always available in analytical laboratories (Farowski et al, 2010;Fatiguso et al, 2017;McShane & Wang, 2017;Müller et al, 2017;Schmitt-Hoffmann, Roos, Maares, et al, 2006;Toussaint et al, 2017;Verweij-van Wissen et al, 2012). To the best of our knowledge, this is the first HPLC method with UV detection developed for the determination of ISC in patients plasma, which uses commonly available equipment and still offers a sensitivity two or eight times higher (0.025 vs 0.05 and 0.2 μg/mL, respectively) than that of two previously published chromatographic methods not coupled with mass spectrometry detection (Jørgensen et al, 2017;Verweij-van Wissen et al, 2012).…”

Section: Discussionmentioning

confidence: 99%

“…TDM of ISC is also recommended in subjects with severe hepatic impairment, as little is known about the drug pharmacokinetic properties in this group of patients (Desai, Schmitt-Hoffmann, Mujais, & Townsend, 2016;European Medicines Agency, 2015). Some analytical methods have been reported so far for the determination of ISC in human plasma and most of them employed mass spectrometry or fluorescence detection (Farowski et al, 2010;Fatiguso et al, 2017;Jørgensen, Andersen, Astvad, & Arendrup, 2017;McShane & Wang, 2017;Müller et al, 2017;Schmitt-Hoffmann, Roos, Maares, et al, 2006;Toussaint et al, 2017). Alternatively, a method based on ultra-performance liquid chromatography (UPLC) coupled with UV detection has also been developed (Verweij-van Wissen, Burger, Verweij, Aarnoutse, & Brüggemann, 2012).…”

Section: Introductionmentioning

confidence: 99%

“…shows two representative chromatograms of plasma samples of patients at steady state receiving the recommended maintenance oral dose of 200 mg daily of ISC. Previously published methods for the determination of ISC levels in plasma involved the use of UPLC, LC-MS/MS or fluorescence detectors, which are not always available in analytical laboratories(Farowski et al, 2010;Fatiguso et al, 2017;McShane & Wang, 2017;Müller et al, 2017;Schmitt-Hoffmann, Roos, Maares, et al, 2006;Toussaint et al, 2017;Verweij-van Wissen et al, 2012). This assay is currently employed successfully for the routine TDM of ISC in our diagnostic unit.4 | DISCUSSION AND CONCLUSIONSThe present paper describes the development and validation of a simple, accurate, selective and sensitive HPLC assay with UV detection for the quantification of ISC in human plasma.…”

mentioning

confidence: 97%

See 4 more Smart Citations

A sensitive and validated HPLC‐UV method for the quantitative determination of the new antifungal drug isavuconazole in human plasma

Nannetti

Pagni

Palù

et al. 2018

Biomedical Chromatography

View full text Add to dashboard Cite

Isavuconazole is a broad-spectrum triazole antifungal drug recently approved for the therapy of both invasive aspergillosis and mucormycosis. To support a widespread therapeutic drug monitoring of isavuconazole, a simple, sensitive, and precise high-performance 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-solid-phase extraction and a chromatographic separation on a Waters XTerra RP (150 × 4.6 mm, 3.5 μm) column using an isocratic mobile phase of ammonium acetate buffer (pH 8.0, 10 mm) and acetonitrile (45:55, v/v). The UV detection was performed at 285 nm. This method was linear (correlation coefficients ≥0.998), specific (no interference with plasma components or various potentially co-administrated drugs), sensitive (lower limit of quantification of 0.025 μg/mL), reproducible (coefficients of variation were ≤7.9%) and accurate (deviations ranged from -5.0 to 8.0%) over the range of 0.025-10 μg/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.

show abstract