Chan G L, Axelson J E, Abbott F S, Kerr C R, McErlane K M
Division of Biopharmaceutics and Pharmacokinetics, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada.
J Chromatogr. 1987 Jul 3;417(2):295-308. doi: 10.1016/0378-4347(87)80123-8.
A gas-liquid chromatographic method with electron-capture detection using a capillary column with the inlet in the splitless injection mode is reported for the assay of propafenone. A 25 m X 0.31 mm cross-linked, 5% phenylmethylsilicone-coated fused-silica capillary column was employed for all analyses. The present method provides improved selectivity and sensitivity over other existing gas chromatographic and high-performance liquid chromatographic (HPLC) methods. Linearity was observed in the ranges 2.5-50 and 10-100 ng/ml. The coefficient of variation was found to be less than 10% over the concentration ranges studied. Application of the developed method is demonstrated by measuring serum propafenone concentrations over 24 h in a normal healthy volunteer after a single oral dose of propafenone and by measuring trough plasma propafenone concentrations at steady state in patients receiving this new antiarrhythmic drug. Validity of the present method is further demonstrated by comparison of analytical results obtained from measurement of patient samples using a modified published HPLC method.
报道了一种采用毛细管柱、分流进样模式、电子捕获检测的气-液色谱法测定普罗帕酮。所有分析均使用一根25 m×0.31 mm交联、5%苯基甲基硅氧烷涂层的熔融石英毛细管柱。与其他现有的气相色谱法和高效液相色谱法(HPLC)相比,本方法具有更高的选择性和灵敏度。在2.5 - 50 ng/ml和10 - 100 ng/ml范围内观察到线性关系。在所研究的浓度范围内,变异系数小于10%。通过测定一名正常健康志愿者单次口服普罗帕酮后24小时内的血清普罗帕酮浓度,以及测定接受这种新型抗心律失常药物的患者稳态时的谷值血浆普罗帕酮浓度,证明了所开发方法的应用。通过比较使用改良的已发表HPLC方法测定患者样品所获得的分析结果,进一步证明了本方法的有效性。