Research output: Contribution to journal › Article › peer-review
Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human Plasma. / Oleinik, Galina A.; Koval, Vladimir V.; Usova, Svetlana V. et al.
In: Molecules, Vol. 27, No. 11, 3577, 01.06.2022.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human Plasma
AU - Oleinik, Galina A.
AU - Koval, Vladimir V.
AU - Usova, Svetlana V.
AU - Shishkina, Larisa N.
AU - Chernonosov, Alexander A.
N1 - Funding Information: This research was supported by the Russian Science Foundation (grant no. 22-24-00697).We thank the State Research Center of Virology and Biotechnology VECTOR for providing blood plasma samples from volunteers who participated in the clinical trial of NIOCH-14 for the practical application of the presented method. We are grateful to A.Ya. Tikhonov and B.A. Selivanov for kindly providing the reagents ST-246 and 2-hydroxy-N-{3,5-dioxo-4-azatetracyclo [5.3.2.02.6.08.10]dodec-11-en-4-yl}-5-methylbenzamide. Publisher Copyright: © 2022 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2022/6/1
Y1 - 2022/6/1
N2 - 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 R2 > 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.
AB - 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 R2 > 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.
KW - LC-MS/MS
KW - MRM
KW - NIOCH-14
KW - plasma
KW - ST-246
KW - tecovirimat
KW - Plasma
KW - Reproducibility of Results
KW - Humans
KW - Tandem Mass Spectrometry/methods
KW - Isoindoles
KW - Chromatography, High Pressure Liquid/methods
KW - Chromatography, Liquid
KW - Benzamides
UR - http://www.scopus.com/inward/record.url?scp=85131620866&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/7951768d-a199-37e9-8fa5-2b84c5af2c5f/
U2 - 10.3390/molecules27113577
DO - 10.3390/molecules27113577
M3 - Article
C2 - 35684513
AN - SCOPUS:85131620866
VL - 27
JO - Molecules
JF - Molecules
SN - 1420-3049
IS - 11
M1 - 3577
ER -
ID: 36566745