title: Quantification of fexofenadine in human plasma by liquid chromatography coupled to electrospray tandem mass spectrometry using mosapride as internal standard.
abstract: A rapid high-performance liquid chromatography/positive ion electrospray tandem mass spectrometry method was developed and validated for the quantification of fexofenadine in human plasma using mosapride as internal standard. Following solid-phase extraction, the analytes were separated using an isocratic mobile phase on a reverse-phase column and analyzed by MS/MS in the multiple reaction monitoring mode using the respective [M+H]+ ions, m/z 502/466 for fexofenadine and m/z 422/198 for the IS. The method exhibited a linear dynamic range of 1-500 ng/mL for fexofenadine in human plasma. The lower limit of quantification was 1 ng/mL with a relative standard deviation of less than 5% for fexofenadine. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. The total chromatographic run time of 2 min for each sample made it possible to analyze more than 400 human plasma samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies.
authors.affiliation: Biopharmaceutical Research, Suven Life Sciences Ltd, Serene Chambers, Road # 7, Banjara Hills, Hyderabad 500034, India. ramakrishna_nirogi@yaoo.co.in
authors.forename: Ramakrishna V S
authors.initials: RV
authors.lastname: Nirogi
authors.forename: Vishwottam N
authors.initials: VN
authors.lastname: Kandikere
authors.forename: Manoj
authors.initials: M
authors.lastname: Shukla
authors.forename: Koteshwara
authors.initials: K
authors.lastname: Mudigonda
authors.forename: Santosh
authors.initials: S
authors.lastname: Maurya
authors.forename: Prashanth
authors.initials: P
authors.lastname: Komarneni
mesh_terms: D001549:Benzamides / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D009025:Morpholines / Q000032:analysis; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D053719:Tandem Mass Spectrometry / Q000379:methods*; D016593:Terfenadine / Q000031:analogs & derivatives* / Q000097:blood
chemical_list: D001549:Benzamides; D009025:Morpholines; D016593:Terfenadine; C093230:fexofenadine; C062720:mosapride