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HERO ID
2568357
Reference Type
Journal Article
Title
A rapid and sensitive HPLC-APCI-MS/MS method determination of fluticasone in human plasma: application for a bioequivalency study in nasal spray formulations
Author(s)
Byrro, RM; César, IC; de Santana e Silva Cardoso, FF; Mundim, IM; Teixeira, L; Bonfim, RR; Gomes, SA; Pianetti, GA
Year
2012
Is Peer Reviewed?
Yes
Journal
Journal of Pharmaceutical and Biomedical Analysis
ISSN:
0731-7085
EISSN:
1873-264X
Volume
61
Page Numbers
38-43
Language
English
PMID
22178434
DOI
10.1016/j.jpba.2011.11.018
Web of Science Id
WOS:000299861700006
Abstract
A sensitive method for the determination of fluticasone in plasma was developed using high performance liquid chromatography with tandem mass spectrometric detection, whereas beclomethasone was used as internal standard. The analytes were extracted with a simple liquid-liquid extraction from the plasma samples and separated on an ACE C(18) 50 × 4.6 mm i.d.; 5 μm particle size column with a mobile phase consisting of acetonitrile - 0.01% formic acid (48:52, v/v) at a flow rate of 1 ml/min. Detection was achieved by an Applied Biosystems API 5000 mass spectrometer (LC-MS/MS) set at unit resolution in the multiple reaction monitoring mode. Atmospheric pressure chemical ionization (APCI) was used for ion production. The mean recovery for fluticasone propionate was 85%, with a lower limit of quantification set at 2 pg/mL. The validated analytical method was applied to a bioequivalence study of fluticasone propionate administered by nasal spray formulations in human volunteers.
Keywords
Fluticasone; Nasal spray; HPLC-APCI-MS/MS; Plasma; Bioequivalence
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