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目的 :建立一种脑复康 (乙酰胺吡咯烷酮 )注射液的含量测定方法 ,以考察上市药品脑复康注射液的质量。方法 :采用高效液相色谱法[1,2 ] ,用ZORBAXSB -C18柱 ,以甲醇 -水 (2 5∶75 )为流动相 ,在波长 2 15nm处进行检测。结果 :乙酰胺吡咯烷酮在 10 0 15 5～ 5 0 0 775 μg·ml-1浓度范围内 ,线性关系良好 ,r=0 9998(n =6 ) ,平均回收率 10 1 12 % ,RSD =0 93% (n =5 )。结论 :本法适用于脑复康注射液的成品检验。
Objective: To establish a method for the determination of Naofukong (acetaminophenone) injection in order to investigate the quality of the listed drug Naofukang injection. Methods: High performance liquid chromatography [1, 2] was performed on a ZORBAX SB-C18 column with methanol-water (25:75) as the mobile phase at a wavelength of 215 nm. Results: Acetamipramine showed a good linearity at a concentration range of 10 0 5 5 0 0 775 μg · ml -1, r = 0 9998 (n = 6), with an average recovery of 10 1 12% and a RSD of 0 93 % (n = 5). Conclusion: This method is applicable to the finished product testing of Naofukang injection.