Acta Pharm. 63 (2013) 141-158

 

full paper

Original research paper

 

Quantitation of nitrofurantoin in human plasma by liquid chromatography tandem mass spectrometry

DINESH S. PATEL, NAVEEN SHARMA, MUKESH C. PATEL, BHAVIN N. PATEL, PRANAV S. SHRIVASTAV and MALLIKA SANYAL

pranav_shrivastav@yahoo.com; bhavinpatel27@rediffmail.com

1 Chemistry Department, Pramukh Swami Science and H.D. Patel Arts College, Sarva Vidyalaya Campus, Kadi-382715, Gujarat, India

2 Bio-Analytical Laboratory, Cliantha Research Ltd., Bodakdev, Ahmedabad-380054, Gujarat, India

3 Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad-380009, Gujarat, India

4 Department of Chemistry, St. Xavier’s College, Navrangpura, Ahmedabad-380009, Gujarat, India

Accepted November 9, 2012

 

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