复方肝浸膏胶囊（片）中维生素 B1、B2的含量及含量均匀度测定

目的:建立复方肝浸膏制剂中维生素B_1、B_2的含量及含量均匀度测定方法。方法:采用HPLC法,色谱柱为C18柱,流动相为甲醇:0.02 mol/L庚烷磺酸钠水溶液(含0.1%三乙胺,用磷酸调节pH至5.5(20∶80)),检测波长为260 nm,流速为1.0 m L/min,柱温为30℃。结果:维生素B11.9~62.0μg/m L线性良好(R~2=0.999 8),平均回收率101.33%,RSD为0.79%(n=6),维生素B20.5~16.0μg/m L线性良好(R~2=0.999 7),平均回收率97.64%,RSD为1.38%(n=6)。结论:本文所建立的HPLC含量测定方法简便、快速、准确,可用于复方肝浸膏制剂中维生素B1、B2的含量测定及含量均匀度测定。

Determination of content and content uniformity of thiamine and ribofla-vin in Compound Hepar Extractum Capsules(Tablets)

Objective:To establish an HPLC method for the determination of content and content uniformity of thiamine and ri-boflavin in Compound Hepar Extractum Capsules(Tablets).Methods:HPLC with C18 column was used.Methanol:0.02 mol· L -1 , Sodium 1 -heptanesulfonate (20∶80)(include 0.1 % triethylamine,adjusted pH to 5.5 with phosphoric acid)was used as a mobile phase.The detection wave length was 260 nm.Results:The linear range of thiamine was 1 .9 ~62.0 μg·mL -1 ,(R2 =0.999 8),the average recovery rate was 101 .33% (RSD was 0.79%,n =6).The linear range of riboflavin was 0.5 ~16.0 μg· mL -1 ,(R2 =0.999 7),the average recovery rate was 97.64%(RSD was 1 .38%,n =6).Conclusion:This method is simple,quick and accurate and can be used for the determination of the content and content uniformity of thiamine and riboflavin in Compound Hepar Extractum Capsules(Tablets).