Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
1223970 | Journal of Pharmaceutical and Biomedical Analysis | 2006 | 9 Pages |
A simple, sensitive and rapid liquid chromatography/tandem mass spectrometry (LC–MS/MS) method was developed and validated for the quantification of gabapentin, a new antiepileptic drug, in human plasma using its structural analogue, 1,1-cyclohexane diacetic acid monoamide (CAM) as internal standard. The method involved a simple protein precipitation by means of acetonitrile followed by a rapid isocratic elution with 10 mM ammonium formate buffer/acetonitrile (20/80, v/v, pH 3.0) on Waters Symmetry® C18 reversed phase chromatographic column and analyzed by mass spectrometry in the multiple reaction monitoring mode. The precursor to product ion transitions of m/z 172 → 154 and m/z 200 → 182 were used to measure the analyte and the IS, respectively. The assay exhibited a linear dynamic range of 40–10 000 ng/mL for gabapentin in human plasma. The limit of detection and lower limit of quantification in human plasma were 10 and 40 ng/mL, respectively. Acceptable precision and accuracy were obtained for concentrations over the standard curve ranges. A run time of 2 min for each sample made it possible to analyze a throughput of more than 400 human plasma samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies.