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.
建立了一种采用固相萃取、毛细管气相色谱以及电子轰击电离（EI）模式下的质量选择检测法，用于测定人血浆中的曲马多（2-[(二甲氨基)甲基]-1-(3-甲氧基苯基)环己醇）。该方法的优点是灵敏度高、选择性好，且在2-500 ng/ml的浓度范围内具有线性关系。使用奈福泮作为内标进行定量，检测限为1 ng/ml。日内精密度试验的浓度相对标准偏差在4.5%至6.0%之间。日间准确度在1.0%至4.0%之间。该方法用于生物等效性研究中曲马多的测定。
