高效液相色谱法测定石杉碱甲胶囊溶出度

Determination the Dissolution of Huperzine A Capsules by HPLC

目的建立石杉碱甲胶囊溶出度的高效液相色谱方法。方法以盐酸溶液(9→1 000)100 mL为溶出递质,转速为35 r.min-1,取样时间为30 min,采用溶出度第三法测定。结果石杉碱甲在0.13～1.02μg.mL-1的浓度范围内,线性关系良好。线性方程为:A=103.95C-0.15(r=1.000 0);平均回收率为98.0%(RSD=0.7%);4批样品30 min平均溶出度均>80%。结论该方法简便、准确、重现性好,可用于石杉碱甲胶囊的质量控制。

Objective To establish a method for determining the dissolution of Huperzine A capsules by HPLC. Methods 100 mL Hydrochloric acid （9→1 000） was taken as solvent with the rotating speed at 35 r ·min^-1, and the sampling time 30 min. The dissolution of Huperzine A capsules was determined by dissolution test 3. Results The standard curve of Huperzine A showed as a good linear relationship in the range of 0. 13 - 1.02 μg ·mL^-1 （r = 1.000 0,n =6） ;The average recovery rate was 98.0% （RSD = 0.7%, n = 9）. The mean cumulative dissolutions of four batches of samples were all above 80%. Conclusion The method is simple, accurate and reproducible,which can be used for the quality control of. Huperzine A capsules.