复方肝浸膏胶囊(片)中维生素B_1、B_2的含量及含量均匀度测定

Determination of content and content uniformity of thiamine and riboflavin in Compound Hepar Extractum Capsules( Tablets)

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。

Objective：To establish an HPLC method for the determination of content and content uniformity of thiamine and riboflavin 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 - 16.0μg · 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）.