Determination of flurbiprofen in pharmaceutical preparations by GC–MS

Abstract

This article describes a gas chromatography–mass spectrometry (GC–MS) method for the determination of flurbiprofen in pharmaceutical preparations. The method is based on the derivatization of flurbiprofen with N-methyl-N-(trimethylsilyl)trifluoroacetamide (MSTFA). For GC–MS, electron ionization mode (EI = 70 eV) and selected ion monitoring (SIM) mode were used for quantitative analysis (m/z 180 for flurbiprofen). Calibration curve was linear between the concentration range of 0.25–5.0 μg/mL. Intra- and inter-day precision values for flurbiprofen were less than 3.64, and accuracy (relative error) was better than 2.67%. The mean recovery of flurbiprofen was 99.4% for pharmaceutical preparations. The limits of detection and quantification of flurbiprofen were 0.05 and 0.15 μg/mL, respectively. No interference was found from tablet excipients at the selected assay conditions. Also, the method was applied for the quality control of five commercial flurbiprofen dosage forms to quantify the drug and to check the formulation content uniformity. Keywords: Flurbiprofen, Derivatization, Gas chromatography–mass spectrometry, Validation, Pharmaceutical tablet