高效液相色谱法测定复方黄连素片中盐酸小檗碱的溶出度

Dissolution Testing of Berberine Hydrochloride in Fufang Huangliansu Tablets by High Performance Liquid Chromatography

目的:用高效液相色谱法测定复方黄连素片中盐酸小檗碱的溶出度。方法:采用转篮法测定复方黄连素片中盐酸小檗碱的溶出度,以高效液相色谱法定量。色谱柱为RP-C18柱(5μm,250 mm×4.6 mm);流动相为0.033 mol/L,磷酸二氢钾-乙腈(60∶40);流速为1.0 mL/min;检测波长265 nm;进样量为10μL。结果:盐酸小檗碱在0.992~9.920μg/mL范围内有良好的线性关系(r=0.999 8),平均回收率为100.2%,RSD=0.38%(n=9),3批样品45 min溶出度均在75%以上。结论:高效液相法测定溶出度简便、准确、灵敏度高,可用于复方黄连素片中盐酸小檗碱溶出度的测定。

Objective：Testing the dissolution of berberine hydrochloride in Fufang Huangliansu tablets by high performance liquid chromatography（HPLC）. Methods：Basket method was used to determine the dissolution of Fufang Huangliansu tablets. HPLC method was established to determine the dissolution. The chromatography conditions were as follows：RP-C18（5 μm,250 mm× 4.6 mm） column,mobile phase was 0.033 mol/L KH2PO4- CH2CN（60：40）,velocity of flow was 1.0 mL/min,detection wave length at 265 nm and the injected volume being 10 μL. Results：The linear ranges of determination of berberine hydroehloride was 0.992-9.920 μg/mL （r=0.999 8）. The average recoveries was 100.2%,RSD=0.38%（n=9）. The dissolutions of three batches of samples in 45 rain were higher than 70%. Conclusion：The method is very easy,accurate and reliable. It can be used for determination of dissolution of berberine hydrochloride.