Acta Pharmaceutica, Vol. 63 No. 2, 2013.
Original scientific paper
https://doi.org/10.2478/acph-2013-0012
Quantitation of nitrofurantoin in human plasma by liquid chromatography tandem mass spectrometry
DINESH S. PATEL
; Chemistry Department, Pramukh Swami Science and H.D. Patel Arts College, Sarva Vidyalaya Campus, Kadi-382 715, Gujarat, India; Bio-Analytical Laboratory, Cliantha Research Ltd., Bodakdev, Ahmedabad-380054, Gujarat, India
NAVEEN SHARMA
; Bio-Analytical Laboratory, Cliantha Research Ltd., Bodakdev, Ahmedabad-380054, Gujarat, India
MUKESH C. PATEL
; 1 Chemistry Department, Pramukh Swami Science and H.D. Patel Arts College, Sarva Vidyalaya Campus, Kadi-382 715, Gujarat, India
BHAVIN N. PATEL
; Bio-Analytical Laboratory, Cliantha Research Ltd., Bodakdev, Ahmedabad-380054, Gujarat, India; Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad-380009, Gujarat, India
PRANAV S. SHRIVASTAV
; Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad-380009, Gujarat, India
MALLIKA SANYAL
; Department of Chemistry, St. Xavier’s College, Navrangpura, Ahmedabad-380009, Gujarat, India
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.
Keywords
nitrofurantoin; LC-MS/MS; solid phase extraction; human plasma; bioequivalence; incurred sample reanalysis
Hrčak ID:
97694
URI
Publication date:
30.6.2013.
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