普罗帕酮对映体的高效液相色谱分析方法研究  

A Study of Propafenone Enantiomers in the Human Plasma with High Performance Liquid Chromatography

作　　者：张金安 陈超君 相延英[3] 张毅[4] 

机构地区：[1]湖北省武警总队医院药剂科,武汉430070 [2]武汉华龙生物制药有限公司,430040 [3]解放军第161医院,武汉430030 [4]华中科技大学同济医学院基础医学院生理教研室,武汉430030

出　　处：《医药导报》2003年第8期526-528,共3页Herald of Medicine

摘　　要：目的 :建立人体血浆中S 和R 普罗帕酮的高效液相色谱分析方法 ,为普罗帕酮对映体的临床药理学研究提供分析技术。方法 :采用内标法和反相高效液相色谱法 ,以甲醇∶水∶冰乙酸 :三乙胺 ( 5 3∶47∶1.6∶0 .5 )为流动相 ,ShaudouHypersil ODS柱为固定相 ,Li 1115为内标 ,流速为 1.2mL·min 1 ,在紫外检测波长 2 5 0nm处检测S 和R 普罗帕酮标准品和血浆中提取S 和R 普罗帕酮标准品的含量。结果 :该方法的灵敏度AUF为 0 .0 1,最低检测限 2 0ng ,标准曲线的线性范围为 5 0～ 80 0 μg·L 1 ,S 和R 普罗帕酮的平均回收率分别为 86.0 3 %和 84.17% ,日内变异系数分别为 8.2 %和6.6%。结论 :该法灵敏度高 ,重现性好 ,可用于普罗帕酮对映体的临床药理学研究。Objective:To set up an HPLC method for the determination of propafenone enantiomers in the human plasma and to provide analytic techniques for the clinical pharmacological study of the propafenone enantiomers. Methods:The internal standard method and reversed phase high performance liquid chromatography were used for the determination of the concentrations of standard substances of S propafenone and R propafenone and those of the coresponding enantiomers extracted from the human plasma. The mobile phase was methanol water glacial acetic acid triethylamine in a ratio of 53∶47∶1.6∶0.5 by volume and the stationary phase was a column composed of Shaudou Hypersil ODS. Li 1115 served as the internal standard and the flow rate was 1.2 mL·min 1 . The detection was carried out at UV 254 nm. Results:The sensitivity of the method was 0.01 AUF, the lowest detection limit was 20 ng, the linear range of the standard curve was from 50 μg·L 1 to 800 μg·L 1 . The average rates of recovery of S propafenone and R propafenone were 86.03% and 84.17%, respectively, their RSD within a day being 8.2% and 6.6%, respectively. Conclusion:The method was shown to have a high sensitivity and good reproducibility. It may therefore be used in the clinical pharmacological study of propafenone enantiomers.

关 键 词：普罗帕酮 对映体 反相高效液相色谱法 血药浓度 

分 类 号：R972.2[医药卫生—药品] R969.1[医药卫生—药学]