title: Quantitation of nitrofurantoin in human plasma by liquid chromatography tandem mass spectrometry.
abstract: A reliable, selective and sensitive LC-MS/MS assay has been proposed for the determination of nitrofurantoin in human plasma. The analyte and nitrofurazone were extracted from 100 μL of human plasma via SPE on Strata-X 33 μm extraction cartridges. Chromatography was done on a BDS Hypersil C18 (100 mm × 4.6 mm, 5 μm) column under isocratic conditions. Quantitation was done using the multiple reaction monitoring (MRM) mode for deprotonated precursor to product ion transitions of nitrofurantoin (m/z 237.0 → 151.8) and nitrofurazone (m/z 197.0 → 123.9). The limit of detection and the lowest limit of quantitation of the method were 0.25 ng mL-1 and 5.00 ng mL-1, respectively, with a linear dynamic range of 5.00-1500 ng mL-1 for nitrofurantoin. The intra- -batch and inter-batch precision (RSD, %) was ≤ 5.8 %, while the mean extraction recovery was > 92 %. The method was successfully applied to a bioequivalence study of a 100 mg nitrofurantoin capsule formulation in 36 healthy subjects.
authors.affiliation: Chemistry Department, Pramukh Swami Science and H.D. Patel Arts College, Sarva Vidyalaya Campus, Kadi, Gujarat, India.
authors.forename: Dinesh S
authors.initials: DS
authors.lastname: Patel
authors.forename: Naveen
authors.initials: N
authors.lastname: Sharma
authors.forename: Mukesh C
authors.initials: MC
authors.lastname: Patel
authors.forename: Bhavin N
authors.initials: BN
authors.lastname: Patel
authors.forename: Pranav S
authors.initials: PS
authors.lastname: Shrivastav
authors.forename: Mallika
authors.initials: M
authors.lastname: Sanyal
mesh_terms: D000328:Adult; D000892:Anti-Infective Agents, Urinary / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics; D002214:Capsules; D002853:Chromatography, Liquid / Q000379:methods*; D016903:Drug Monitoring / Q000379:methods; D006801:Humans; D009582:Nitrofurantoin / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics; D009583:Nitrofurazone / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D052616:Solid Phase Extraction / Q000379:methods; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency
chemical_list: D000892:Anti-Infective Agents, Urinary; D002214:Capsules; D009582:Nitrofurantoin; D009583:Nitrofurazone