Quantification of oteseconazole in rat plasma using LC-MS/MS and its application to pharmacokinetic study

Krishna Phani Chandra  Susararla; Om  Shelke; Neetu  Shorgar

doi:10.69857/joapr.v12i4.485

Authors

Krishna Phani Chandra Susararla Pacific Academy of Higher Education and Research University, Udaipur, Rajasthan, India
Om Shelke Sinomune Pharmaceutical Co. Ltd., Wuxi, Jiangsu, China
Neetu Shorgar Pacific Academy of Higher Education and Research University, Udaipur, Rajasthan, India

DOI:

https://doi.org/10.69857/joapr.v12i4.485

Keywords:

Oteseconazole, posaconazole, Bioanalytical methods, rat plasma, Pharmacokinetics

Abstract

Background: Oteseconazole is a new molecule launched for human treatment. However, the information is not available in the public domain for analyzing blood samples. This study describes the method development and validation using LC-MS/MS to measure the concentration of Oteseconazole in rat plasma. Methodology: The analysis method was developed using a phenyl column, which was utilized to accomplish separation. Furthermore, the mobile phase was a combination of acetonitrile and 0.1% formic acid in water, with a ratio of 30:70 (v/v). The sample was introduced into the system at a 1.0 mL/min flow rate, and the injection volume was 10 μLand analyzed for five minutes using mass spectrometer +ESI mode. Results and discussion: MRM is used to quantify Oteseconazole and Posaconazole by analyzing the transitions of their respective m/z values. The concentration ranges of Oteseconazole were 5-100 ng/mL. The correlation coefficient of Oteseconazole was found to be 0. 999. HQC, MQC, LQC, and LLQC precision and accuracy were determined to be 98.60%, 98.69%, 96.11%, and 94.48%, respectively. Respectively, the accuracy recovery of Oteseconazole was determined to be 97.48%. In pharmacokinetic studies, it was observed that Oteseconazole exhibited an average AUC0-t value of 1386 ng-hr/ml and a Cmax value of 44.864 ng/ml in rats. Conclusion: The validated approach has effectively demonstrated the determination of pharmacokinetic parameters after the oral administration of Oteseconazole in Wister rats.

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