Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human Plasma
The aim of this work was to develop and validate a sensitive and robust method of liquid chromatography coupled with tandem mass spectrometry to quantitate ST-246 (tecovirimat) in plasma using an internal standard (2-hydroxy-N-{3,5-dioxo-4-azatetracyclo [5.3.2.02.6.08.10]dodec-11-en-4-yl}-5-methylbe...
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MDPI AG
2022-06-01
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| Series: | Molecules |
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| Online Access: | https://www.mdpi.com/1420-3049/27/11/3577 |
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| author | Galina A. Oleinik Vladimir V. Koval Svetlana V. Usova Larisa N. Shishkina Alexander A. Chernonosov |
| author_facet | Galina A. Oleinik Vladimir V. Koval Svetlana V. Usova Larisa N. Shishkina Alexander A. Chernonosov |
| author_sort | Galina A. Oleinik |
| collection | DOAJ |
| description | The aim of this work was to develop and validate a sensitive and robust method of liquid chromatography coupled with tandem mass spectrometry to quantitate ST-246 (tecovirimat) in plasma using an internal standard (2-hydroxy-N-{3,5-dioxo-4-azatetracyclo [5.3.2.02.6.08.10]dodec-11-en-4-yl}-5-methylbenzamide). The method was validated in negative multiple reaction monitoring mode following recommendations of the European Medicines Agency for the validation of bioanalytical methods. The calibration curve for the analyte was linear in the 10–2500 ng/mL range with determination coefficient R<sup>2</sup> > 0.99. Intra- and inter-day accuracy and precision for three concentrations of quality control were <15%. Testing of long-term stability of ST-246 (tecovirimat) in plasma showed no degradation at −20 °C for at least 3 months. The method was applied to a clinical assay of a new antipoxvirus compound, NIOCH-14. Thus, the proposed method is suitable for therapeutic drug monitoring of ST-246 (tecovirimat) itself and of NIOCH-14 as its metabolic precursor. |
| first_indexed | 2024-03-10T01:03:28Z |
| format | Article |
| id | doaj.art-457d653f0ac6428886f0f29545e9f22f |
| institution | Directory Open Access Journal |
| issn | 1420-3049 |
| language | English |
| last_indexed | 2024-03-10T01:03:28Z |
| publishDate | 2022-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Molecules |
| spelling | doaj.art-457d653f0ac6428886f0f29545e9f22f2023-11-23T14:31:02ZengMDPI AGMolecules1420-30492022-06-012711357710.3390/molecules27113577Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human PlasmaGalina A. Oleinik0Vladimir V. Koval1Svetlana V. Usova2Larisa N. Shishkina3Alexander A. Chernonosov4Institute of Chemical Biology and Fundamental Medicine SB RAS, Lavrentiev Ave. 8, Novosibirsk 630090, RussiaInstitute of Chemical Biology and Fundamental Medicine SB RAS, Lavrentiev Ave. 8, Novosibirsk 630090, RussiaState Research Center of Virology and Biotechnology VECTOR, Koltsovo 630559, Novosibirsk Oblast, RussiaState Research Center of Virology and Biotechnology VECTOR, Koltsovo 630559, Novosibirsk Oblast, RussiaInstitute of Chemical Biology and Fundamental Medicine SB RAS, Lavrentiev Ave. 8, Novosibirsk 630090, RussiaThe aim of this work was to develop and validate a sensitive and robust method of liquid chromatography coupled with tandem mass spectrometry to quantitate ST-246 (tecovirimat) in plasma using an internal standard (2-hydroxy-N-{3,5-dioxo-4-azatetracyclo [5.3.2.02.6.08.10]dodec-11-en-4-yl}-5-methylbenzamide). The method was validated in negative multiple reaction monitoring mode following recommendations of the European Medicines Agency for the validation of bioanalytical methods. The calibration curve for the analyte was linear in the 10–2500 ng/mL range with determination coefficient R<sup>2</sup> > 0.99. Intra- and inter-day accuracy and precision for three concentrations of quality control were <15%. Testing of long-term stability of ST-246 (tecovirimat) in plasma showed no degradation at −20 °C for at least 3 months. The method was applied to a clinical assay of a new antipoxvirus compound, NIOCH-14. Thus, the proposed method is suitable for therapeutic drug monitoring of ST-246 (tecovirimat) itself and of NIOCH-14 as its metabolic precursor.https://www.mdpi.com/1420-3049/27/11/3577MRMLC-MS/MStecovirimatST-246NIOCH-14plasma |
| spellingShingle | Galina A. Oleinik Vladimir V. Koval Svetlana V. Usova Larisa N. Shishkina Alexander A. Chernonosov Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human Plasma Molecules MRM LC-MS/MS tecovirimat ST-246 NIOCH-14 plasma |
| title | Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human Plasma |
| title_full | Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human Plasma |
| title_fullStr | Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human Plasma |
| title_full_unstemmed | Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human Plasma |
| title_short | Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human Plasma |
| title_sort | development and validation of a method of liquid chromatography coupled with tandem mass spectrometry for quantification of st 246 tecovirimat in human plasma |
| topic | MRM LC-MS/MS tecovirimat ST-246 NIOCH-14 plasma |
| url | https://www.mdpi.com/1420-3049/27/11/3577 |
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