Abstract
A bioequivalence study was proved of generic Febuxostat 80 mg tablets (T) in healthy volunteers.For this purpose, Authors developed a simple, sensitive, selective, rapid, rugged and reproducible liquid chromatography–tandem mass spectrometry method for the quantification of Febuxostat (FB) in human plasma using Febuxostat D7 (FBD7) as an internal standard (IS) was used. Chromatographic separation was performed on Ascentis Express C18 (50x4.6 mm, 3.5 μ) column. Mobile phase composed of 10 mM Ammonium formate: Acetonitrile (20:80 v/v), with 0.8 mL/min flow-rate. Drug and IS were extracted by Liquid- liquid extraction. FB and FBD7 were detected with proton adducts at m/z 317.1→261.1 and 324.2→262.1 in multiple reaction monitoring (MRM) positive mode respectively. The method was validated with the correlation coefficients of (r2) ≥ 0.9850 over a linear concentration range of 1.00-8000.00 ng/mL. This method demonstrated intra and inter-day precision within 2.64 to 3.88 and 2.76 to 8.44% and accuracy within 97.33 to 99.05 and 100.30 to 103.19% for FB. This method is successfully applied in the Bioequivalence study of 9 human volunteers.
Highlights
Febuxostat is chemically 2-(3-cyano-4-isobutoxyphenyl)-4methyl-1,3- thiazole-5- carboxylic acid
Literature survey reveals that, there are few methods were reported for quantification of Febuxostat by using UV (Bagga et al 2011; Sheth et al 2012), Liquid chromatography (LC) (Gunda et al 2012a; Kumaraswamy Gandla et al 2012; Cong et al 2010; Naresh Chandra Reddy & Chandra Sekhar 2012; Nageswara Rao et al 2012; Gunda et al 2012b; Muvvala1 et al 2012; Yamamoto et al 1995; Menon et al 2011; Mathrusri Annapurna et al 2012), UPLC (Sahu et al 2012), UPLC-MS (Lukram et al 2012; Zhang et al 2012)
Xitao ding et al (Ding et al 2012) developed the method in rat plasma using protein precipitation extraction method by using acetonitrile as an precipitating agent. They developed with the linearity range of 10–2000 ng/mL for Febuxostat and used midazolam as internal standard and applied to determinate of Febuxostat in rat plasma for pharmacokinetic study
Summary
Febuxostat is chemically 2-(3-cyano-4-isobutoxyphenyl)-4methyl-1,3- thiazole-5- carboxylic acid. Liquid chromatography -Mass spectrometry (LC) (Kadivar et al 2011; Ding et al 2012; Wang et al 2012) These methods have been reported for the quantitative estimation of Febuxostat in pharmaceutical (Bagga et al 2011; Sheth et al 2012; Gunda et al 2012a; Kumaraswamy Gandla et al 2012; Cong et al 2010; Naresh Chandra Reddy & Chandra Sekhar 2012; Nageswara Rao et al 2012; Gunda et al 2012b; Muvvala et al 2012; Sahu et al 2012; Kadivar et al 2011) and biological fluids (Yamamoto et al 1995; Menon et al 2011; Lukram et al 2012; Zhang et al 2012; Ding et al 2012; Wang et al 2012). They developed the method with linear range of 10.00-5000.00 ng/mL for Febuxostat and used Febuxostat-d7 as an internal standard and performed the pharmacokinetic study in healthy chinese volunteers
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