title: Determination of febuxostat in human plasma using ultra-performance liquid chromatography tandem mass spectrometry.
abstract: A rapid and sensitive liquid chromatography-tandem mass spectrometry method has been developed and validated for the determination of febuxostat in human plasma. The liquid-liquid extraction technique was used for the extraction of febuxostat from human plasma using trandolapril as the internal standard (IS). Chromatography was performed on a ultra-performance liquid chromatography (UPLC) BEH C18, 50 mm X 2.1 mm, 1.7 µm particle size column, with the mobile phase consisting of 0.1% formic acid and acetonitrile (in a 25:75 ratio), followed by detection using mass spectrometry. The method involves a simple reversed isocratic chromatography condition and mass spectrometry detection, which enables detection at sub-microgram levels. The method was validated and the lower limit of quantification for febuxostat was found to be 0.075 µg/ml. The mean recovery for febuxostat ranged from 100.9 to 106.5%. This method increased the sensitivity and selectivity; resulting in high-throughput analysis of febuxostat using commercially available IS for pharmacokinetic, bioavailability, and bioequivalence studies, with a chromatographic run time of 1.5 min only.
authors.affiliation: LifeSan Clinical Research, Division of Centaur Pharmaceuticals Pvt. Ltd, Vakola, Santacruz (East), Mumbai, India. ojitkr@yahoo.co.in
authors.forename: Ojikumar
authors.initials: O
authors.lastname: Lukram
authors.forename: Shivaji
authors.initials: S
authors.lastname: Parmar
authors.forename: Amit
authors.initials: A
authors.lastname: Hande
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000191:economics / Q000379:methods*; D016903:Drug Monitoring / Q000191:economics / Q000379:methods; D000069465:Febuxostat; D006074:Gout Suppressants / Q000097:blood*; D006801:Humans; D057230:Limit of Detection; D059625:Liquid-Liquid Extraction / Q000191:economics / Q000379:methods; D053719:Tandem Mass Spectrometry / Q000191:economics / Q000379:methods*; D013844:Thiazoles / Q000097:blood*; D013997:Time Factors
chemical_list: D006074:Gout Suppressants; D013844:Thiazoles; D000069465:Febuxostat