Merslavic M, Zupancic-Kralj L
KRKA Pharmaceuticals, Pharmacokinetics Department, Novo mesto, Slovenia.
J Chromatogr B Biomed Sci Appl. 1997 May 23;693(1):222-7. doi: 10.1016/s0378-4347(97)00066-2.
An analytical method using solid-phase extraction, capillary gas chromatography and mass selective detection in the electron-impact ionization (EI) mode was developed for the determination of tramadol (2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol) in human plasma. The advantages of this method are the high sensitivity and selectivity and the linearity over the concentration range 2-500 ng/ml. Quantification was made using nefopam as an internal standard, and the detection limit was found to be 1 ng/ml. The standard deviations of the intra-day precision test ranged from 4.5 to 6.0% with respect to the concentration. Accuracy ranged from 1.0 to 4.0% (inter-day). The method was used for the determination of tramadol in a bioequivalence study.