Development and Validation of a Quantitative Determination Method for Fluorothiazinone in Human Blood Plasma

被引：0

作者：

Baskhanova, S. N. ^{[1
,2
]}

Savitskii, M. V. ^{[2
,3
]}

Moskaleva, N. E. ^{[1
]}

Samoylov, V. M. ^{[4
]}

Lubenec, N. L. ^{[5
]}

Luyksaar, S. I. ^{[5
]}

Soloveva, A. V. ^{[5
]}

Zolotov, C. A. ^{[5
]}

Zigangirova, N. A. ^{[5
]}

Appolonova, S. A. ^{[1
,3
]}

机构：

[1] Sechenov Univ, Ctr Digital Biodesign & Personalized Healthcare, Minist Hlth Russia, 8-2 Trubetskaya St, Moscow 119991, Russia

[2] Univ Verona, PhD Program Nanosci & Adv Technol, Verona, Italy

[3] Sechenov Univ, Inst Translat Med & Biotechnol, Lab Pharmacokinet & Metabol Anal, 45 Nakhimovskii Prosp, Moscow 117418, Russia

[4] Sechenov Univ, Minist Hlth Russia, 8-2 Trubetskaya St, Moscow 119991, Russia

[5] Minist Hlth Russia, Gamaleya Natl Res Ctr Epidemiol & Microbiol, 18 Gamalei St, Moscow 123098, Russia

来源：

PHARMACEUTICAL CHEMISTRY JOURNAL | 2024年 / 57卷 / 11期

关键词：

quantitative determination; HPLC-MS/MS; fluorothiazinone; plasma; SUPPRESSION; INHIBITORS;

D O I：

10.1007/s11094-024-03083-4

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

An HPLC-MS/MS technique for quantitative determination of the new antibacterial drug fluorothiazinone in human blood plasma using an internal standard was developed and validated. The validation protocol proved the selectivity, accuracy, and precision of the method and the lack of significant carryover, matrix, and sample-dilution effects. The calibration curve was linear in the concentration range 0.1 - 300 ng/mL with a correlation coefficient r(2) > 0.9990. The lower limit of quantitation was 0.1 ng/mL. The studied analyte was shown to be stable during storage in a stock solution (for 6 h at room temperature) and in plasma samples (for 6 h at room temperature, after three freeze-thaw cycles, and for 30 d at -70(degrees)C) and in an autosampler after sample preparation (for 24 h at +10(degrees)C).

引用

页码：1815 / 1821

页数：7

共 23 条

[1]

[Anonymous], 2019, ICH HARMONISED GUIDE

[2]

[Anonymous], 2019, ICH guideline M10 on bioanalytical method validation and study sample analysis-Questions and Answers

[3]

[Anonymous], 2016, APPENDIX NO 6 GUIDEL

[4] Preventative treatment with Fluorothiazinon suppressed Acinetobacter baumannii-associated septicemia in mice [J].