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

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.