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Vol. 35 No. 8 (2023): Vol 35 Issue 8, 2023

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Development and Validation of Bioanalytical Method for the Quantification of Febuxostat in Human K2 EDTA Plasma by LC-MS/MS: Pharmacokinetic Studies in Wister Rats

https://doi.org/10.14233/ajchem.2023.28162
M. Hima Bindu
Department of Pharmaceutical Analysis, GITAM Deemed to be University, Vishakapatnam-530045, India
https://orcid.org/0009-0008-5662-2104
Gubbiyappa Shiva Kumar
Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Hyderabad-502329, India
https://orcid.org/0000-0002-9075-6535

Corresponding Author(s) : Gubbiyappa Shiva Kumar

sgubbiya@gitam.edu

Asian Journal of Chemistry, Vol. 35 No. 8 (2023): Vol 35 Issue 8, 2023

Abstract

A specific, linear and accurate LC-MS/MS method was developed for the determination of febuxostat in human K2 EDTA plasma and it was successfully applied for the pharmacokinetic study in wister rats. Chromatographic isolation of febuxostat and febuxostat D9 were attained on Purosphur C18, 100 × 4.6 mm, 5 μ column with 1.0 mL/min flowing rate. The technique was linear over the standard concentrations ranging from 24.995-7001.401 ng/mL and the regression coefficient was perceived to be ≥ 0.9997. All LLOQ samples % RSD of back computed concentrations varied from 1.00 to 4.01. The analysis of plasma from healthy rats was successfully conducted using the validated LC-MS/MS procedure to quantify the presence of febuxostat. From the pharmacokinetic studies, Tmax, Cmax, T1/2 and AUC0-∞ of the febuxostat tablets were 2.0 ± 0.03 h, 8.85 ± 1.87 ng/mL, 6.34 ± 0.53 h, 95.58 ± 6.37 ng h/mL, respectively.

Keywords

Febuxostat Gout LC-MS/MS Validation Pharmacokinetics
Bindu, M. H., & Kumar, G. S. (2023). Development and Validation of Bioanalytical Method for the Quantification of Febuxostat in Human K2 EDTA Plasma by LC-MS/MS: Pharmacokinetic Studies in Wister Rats. Asian Journal of Chemistry, 35(8), 2015–2020. https://doi.org/10.14233/ajchem.2023.28162
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