HPLC法测定苦参碱注射液的含量

Content of Matrine Injection Determinded by HPLC

目的:建立高效液相色谱法用于苦参碱注射液的含量测定。方法:用十八烷基硅烷健合硅胶柱(5um;250×4.6mm),以硫酸铵缓冲液[取硫酸铵3.3g,十二烷基硫酸钠6g,加水适量溶解并稀释至1000ml,用硫酸溶液调节至 pH3.0]-乙腈=55∶45为流动相;检测波长210nm。结果与相关杂质分离度好,苦参碱最低检出限为4.5μg/ml,线性范围0.2024～1.012mg/ml(R=0.9999),日内和日间精密度 RSD%均小于1%,平均回收率为100.4%(RSD=0.65%)。结论本法适用于苦参碱注射液的含量测定,操作简便、准确度高。

Objective:To establish a HPLC method for determining the concentration of Ma- trine Injection.Methods:Matrine can be separated on ZORBAX Eclipse XDB—C18 column(Sum; 250×4.6mm)with a mixture of ammonium sulfate buffer(ammonium sulfate 3.3g,sodium lauryl sulfate 6.0g was solved with water and diluted to 1000ml,adjusted pH to 3.0 by sulfuric acid solution].acetonitrile(55:45) as mobile phase and detected at 210nm.Results.Matrine was well separated from other impurity with this methods.The detection limits were 4.5ug/ml,the standard curve was linear in the concentration range 0.2024～1.012 mg/ml and the correlation coefficient was 0.9999.The relative standard deviation of precision for intra—day and inter—day were both less than 1.0%.The average recovery was 99.44%(RSD=0.65%).Conclusion:The method is simple and accurate.It is adapt to determine the concentration of Matrine Injection.