Implementation of Isavuconazole in a Fluorescence-Based High-Performance Liquid Chromatography Kit Allowing Simultaneous Detection of All Four Currently Licensed Mold-Active Triazoles
ABSTRACT Isavuconazole (ISZ) is a newly available broad-spectrum triazole agent recently approved for the treatment of both invasive aspergillosis and mucormycosis. The aim of this study was to develop a simple and reliable method for therapeutic drug monitoring (TDM) of ISZ in human plasma samples....
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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American Society for Microbiology
2017-06-01
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| Series: | mSphere |
| Subjects: | |
| Online Access: | https://journals.asm.org/doi/10.1128/mSphere.00098-17 |
| _version_ | 1818836574629003264 |
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| author | René Jørgensen Siri Rytcher Andersen Karen Marie Thyssen Astvad Maiken Cavling Arendrup |
| author_facet | René Jørgensen Siri Rytcher Andersen Karen Marie Thyssen Astvad Maiken Cavling Arendrup |
| author_sort | René Jørgensen |
| collection | DOAJ |
| description | ABSTRACT Isavuconazole (ISZ) is a newly available broad-spectrum triazole agent recently approved for the treatment of both invasive aspergillosis and mucormycosis. The aim of this study was to develop a simple and reliable method for therapeutic drug monitoring (TDM) of ISZ in human plasma samples. The method involves using a kit from ChromSystems intended for TDM of itraconazole (ITZ), posaconazole (PSZ), and voriconazole (VRZ) in serum/plasma for sample preparation and high-performance liquid chromatography, using fluorescence detection with emission and excitation wavelengths set to 261 and 366 nm, respectively. The assay was linear over the ISZ concentration range of 0.2 to 20.0 mg/liter, using a 0.1-ml sample volume. The inter- and intraday coefficients of variation were all below 3.7%, whereas the accuracies ranged from 95.0 to 106.2% and the mean extraction recovery was 91.9%. In addition, the method worked well using four different Vacutainer types, with six different healthy volunteers and under a number of relevant storage conditions. Finally, the ISZ detection could be seamlessly implemented in the TDM kit for VRZ, PSZ, and ITZ, enabling simultaneous detection of all four triazoles. This method proved to be simple, accurate, precise, and well suited for routine analysis work. It has been implemented in our laboratory for the simultaneous quantitative analysis of ISZ, VRZ, PSZ, and ITZ for TDM and pharmacokinetic research. IMPORTANCE Isavuconazole is a new broad-spectrum triazole agent recently approved for the treatment of both invasive aspergillosis and mucormycosis. Currently, there is no consensus regarding the potential need for TDM of isavuconazole, and no therapeutic window has been defined. However, at the ECIL-6 meeting in 2015, it was advised that TDM is indicated in a number of different settings. In this study, we describe a rapid and validated isocratic HPLC method for fluorescence-based detection and quantification of isavuconazole in human plasma/serum samples. The method is simple and efficient with good accuracy and precision and importantly only requires a small volume of patient plasma/serum. Furthermore, this method is highly sensitive and selective and can be detected simultaneously with the three other triazoles, itraconazole, voriconazole, and posaconazole, without the need for expensive mass spectrometry equipment. |
| first_indexed | 2024-12-19T03:08:46Z |
| format | Article |
| id | doaj.art-bd870405a34a4a7caa7e874b04b0fd90 |
| institution | Directory Open Access Journal |
| issn | 2379-5042 |
| language | English |
| last_indexed | 2024-12-19T03:08:46Z |
| publishDate | 2017-06-01 |
| publisher | American Society for Microbiology |
| record_format | Article |
| series | mSphere |
| spelling | doaj.art-bd870405a34a4a7caa7e874b04b0fd902022-12-21T20:38:03ZengAmerican Society for MicrobiologymSphere2379-50422017-06-012310.1128/mSphere.00098-17Implementation of Isavuconazole in a Fluorescence-Based High-Performance Liquid Chromatography Kit Allowing Simultaneous Detection of All Four Currently Licensed Mold-Active TriazolesRené Jørgensen0Siri Rytcher Andersen1Karen Marie Thyssen Astvad2Maiken Cavling Arendrup3Unit of Mycology, Department of Microbiology and Infection Control, Statens Serum Institut, Copenhagen, DenmarkUnit of Mycology, Department of Microbiology and Infection Control, Statens Serum Institut, Copenhagen, DenmarkUnit of Mycology, Department of Microbiology and Infection Control, Statens Serum Institut, Copenhagen, DenmarkUnit of Mycology, Department of Microbiology and Infection Control, Statens Serum Institut, Copenhagen, DenmarkABSTRACT Isavuconazole (ISZ) is a newly available broad-spectrum triazole agent recently approved for the treatment of both invasive aspergillosis and mucormycosis. The aim of this study was to develop a simple and reliable method for therapeutic drug monitoring (TDM) of ISZ in human plasma samples. The method involves using a kit from ChromSystems intended for TDM of itraconazole (ITZ), posaconazole (PSZ), and voriconazole (VRZ) in serum/plasma for sample preparation and high-performance liquid chromatography, using fluorescence detection with emission and excitation wavelengths set to 261 and 366 nm, respectively. The assay was linear over the ISZ concentration range of 0.2 to 20.0 mg/liter, using a 0.1-ml sample volume. The inter- and intraday coefficients of variation were all below 3.7%, whereas the accuracies ranged from 95.0 to 106.2% and the mean extraction recovery was 91.9%. In addition, the method worked well using four different Vacutainer types, with six different healthy volunteers and under a number of relevant storage conditions. Finally, the ISZ detection could be seamlessly implemented in the TDM kit for VRZ, PSZ, and ITZ, enabling simultaneous detection of all four triazoles. This method proved to be simple, accurate, precise, and well suited for routine analysis work. It has been implemented in our laboratory for the simultaneous quantitative analysis of ISZ, VRZ, PSZ, and ITZ for TDM and pharmacokinetic research. IMPORTANCE Isavuconazole is a new broad-spectrum triazole agent recently approved for the treatment of both invasive aspergillosis and mucormycosis. Currently, there is no consensus regarding the potential need for TDM of isavuconazole, and no therapeutic window has been defined. However, at the ECIL-6 meeting in 2015, it was advised that TDM is indicated in a number of different settings. In this study, we describe a rapid and validated isocratic HPLC method for fluorescence-based detection and quantification of isavuconazole in human plasma/serum samples. The method is simple and efficient with good accuracy and precision and importantly only requires a small volume of patient plasma/serum. Furthermore, this method is highly sensitive and selective and can be detected simultaneously with the three other triazoles, itraconazole, voriconazole, and posaconazole, without the need for expensive mass spectrometry equipment.https://journals.asm.org/doi/10.1128/mSphere.00098-17HPLCisavuzonazoleTDMtherapeutic drug monitoringfluorescence detectiontriazoles |
| spellingShingle | René Jørgensen Siri Rytcher Andersen Karen Marie Thyssen Astvad Maiken Cavling Arendrup Implementation of Isavuconazole in a Fluorescence-Based High-Performance Liquid Chromatography Kit Allowing Simultaneous Detection of All Four Currently Licensed Mold-Active Triazoles mSphere HPLC isavuzonazole TDM therapeutic drug monitoring fluorescence detection triazoles |
| title | Implementation of Isavuconazole in a Fluorescence-Based High-Performance Liquid Chromatography Kit Allowing Simultaneous Detection of All Four Currently Licensed Mold-Active Triazoles |
| title_full | Implementation of Isavuconazole in a Fluorescence-Based High-Performance Liquid Chromatography Kit Allowing Simultaneous Detection of All Four Currently Licensed Mold-Active Triazoles |
| title_fullStr | Implementation of Isavuconazole in a Fluorescence-Based High-Performance Liquid Chromatography Kit Allowing Simultaneous Detection of All Four Currently Licensed Mold-Active Triazoles |
| title_full_unstemmed | Implementation of Isavuconazole in a Fluorescence-Based High-Performance Liquid Chromatography Kit Allowing Simultaneous Detection of All Four Currently Licensed Mold-Active Triazoles |
| title_short | Implementation of Isavuconazole in a Fluorescence-Based High-Performance Liquid Chromatography Kit Allowing Simultaneous Detection of All Four Currently Licensed Mold-Active Triazoles |
| title_sort | implementation of isavuconazole in a fluorescence based high performance liquid chromatography kit allowing simultaneous detection of all four currently licensed mold active triazoles |
| topic | HPLC isavuzonazole TDM therapeutic drug monitoring fluorescence detection triazoles |
| url | https://journals.asm.org/doi/10.1128/mSphere.00098-17 |
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