摘要
目的建立了硫酸金刚烷胺注射液中金刚烷胺的含量测定方法。方法采用气相色谱法,色谱柱为SE-30毛细管柱(30 m×0.53 mm,1μm),氮气为载气,FID为检测器,柱温110℃下测定其含量。结果金刚烷胺在0.2～2.0 mg/ml浓度范围内线性关系良好(r>0.9995),平均回收率为99.30%,RSD=2.6%,最低检测限为0.0017 ng。测定三批样品的含量分别为:99.86%、100.7%、102.9%。结论建立的毛细管气相色谱法简单、灵敏、快速、回收率和重现性好,可用作硫酸金刚烷胺注射液的质量控制方法。
Objective To develop a method for the determination of amantadine sulfate in chloride sodium injection by Capillary Gas Chromatography. Methods Capillary GC was adopted for determining the amantadine sulfate in chloride sodium injection with the SE- 30capillary column( 30m ×0. 53 mm,1μm),FID and naphthalene as the internal standard. The column temperature was 110℃,and the carrier gas is N2. Results Under the chromatographic conditions mentioned above,the standard curves were linear in the range of 0. 2 ～ 2. 0 mg/ ml( r > 0. 9995) for amantadine sulfate. The average recovery was 99. 30%( RSD = 2. 6%). Conclusion The method is simple,accurate and suitable for the determination of amantadine sulfate in chloride sodium injection.
出处
《安徽医学》
2013年第10期1526-1528,共3页
Anhui Medical Journal
