Development and Validation of a Stability-Indicating RP-HPLC Method for the Determination of Febuxostat (a Xanthine Oxidase Inhibitor)

Abstract

Febuxostat is a selective inhibitor of xanthine oxidase that is used for the treatment of hyperuricaemia in patients with gout. An isocratic liquid chromatographic method was developed and validated for the determination of febuxostat. Chromatographic separation was achieved on a C18 column using sodium acetate buffer (pH 4.0)-acetonitrile (40:60, v/v), with a flow rate 1.2 mL/min (ultraviolet detection at 254 nm). Linearity was observed in the concentration range of 0.1-200 µg/mL (R(2) = 0.9999) with a linear regression equation of y = 21148x - 2025.1. The limit of quantification was found to be 0.0783 µg/mL and the limit of detection was found to be 0.0257 µg/mL. Febuxostat was subjected to stress conditions of degradation in aqueous solutions, including acidic, alkaline, oxidation, photolysis and thermal degradation. The forced degradation studies were performed by using sodium hydroxide, hydrochloric acid, hydrogen peroxide and thermal and ultraviolet radiation. Febuxostat is more sensitive toward acidic conditions than oxidation and very resistant toward alkaline, thermal and photolytic degradations. The method was validated as per the guidelines of the International Conference on Harmonization. The intra-day and inter-day precision (relative standard deviation) was found to be 0.29-0.41 and 0.63-0.76, respectively. The method is simple, specific, precise, robust and accurate for the determination of febuxostat in pharmaceutical dosage forms (tablets).

Green Electroanalytical Method for Fast Measurement of Xanthine Oxidase Inhibitor Febuxostat

“…The comparison between the green method developed at the BDDE and other analytical methods described in the literature for FBX determination was also performed. The linearity range and the LOD value obtained at the BDDE are comparable to those reported for some chromatographic methods 16,19,20 and capillary electrophoresis. 18 Therefore, the developed electroanalytical method at the BDDE is practically useful for the assay of FBX in pharmaceutical samples, especially due to the extremely short analysis time and low running cost.…”

“…Only a few analytical methods have been described for the determination of FBX, including LC-MS methods for pharmacokinetic applications, [12][13][14][15] HPLC methods with UV detection applied in bioequivalence studies, 16,17 stability-indicating MEKC 18 and RP-HPLC methods 19,20 for quantification in pharmaceutical formulation, spectrofluorometry, 21 HPTLC and spectrophotometry. 22 Compared with those methods, electrochemical techniques have several advantages such as simplicity, low-cost, short analysis time and high sensitivity.…”

Ultra-High Performance Liquid Chromatographic Determination of Genotoxic Impurities in Febuxostat Drug Substance and Products

“…Some developed methods for the quantification of febuxostat and its related compounds in the bulk and formulated products by UPLC [3,[8][9][10][11][12][13][14]26]. These previously published research articles were failed to explain about the probable genotoxic impurities in febuxostat.…”

“…Other subjects were explained about the determination of febuxostat was performed by liquid chromatograph coupled mass spectrometer (LCMS/MS) in human plasma [3][4][5][6], by LC-ultraviolet (UV) [7], by HPLC [8][9][10], by UPLC [11][12][13], and by UPLC/MS in dog plasma [14]. The related compounds of febuxostat were separated and determined at the level 0.10% w/w level or 1000 µg/ml level by UPLC in literature [13].…”

Optimization of UPLC Method for Simultaneous Determination of Rosuvastatin and Rosuvastatin Degradation Products

“…Various analytical methods have been reported in the literature for determination of rosuvastatin in different pharmaceutical dosage forms including combinational products. These include HPTLC, 19 HPLC with ultraviolet detection [20][21][22][23][24] and UPLC with ultraviolet detection. 25 Different HPLC methods with ultraviolet detection have been published for the determination of rosuvastatin degradation products.…”