西沙必利胶囊溶出度测定方法的研究

Determination of the dissolution of cisapride capsules

目的 :建立西沙必利胶囊的溶出度测定方法。方法 :依照《中国药典》,以盐酸溶液 ( 0 .0 5→ 10 0 0 ) 5 0 0 ml为溶出介质 ,转速为 5 0 r/min,分光光度法检测 ,检测波长为 30 8nm。结果 :在 5 .0 5 7～ 12 .136 μg/ml范围内 ( r =0 .9998) ,浓度与其吸收度呈良好线性关系 ,平均回收率为 99.89% ,RSD=0 .2 9%。结论 :该方法操作简便 。

Object: To establish a method for determination of dissolution of cisapride capsules. Methods: The dissolution test was carried out according to Pharmacopoeia of the People's Republic of China. The condition was as follows: using hydrochloric acid solution(0.05→1 000) 500 ml as the solvent, with the rotation speed adjusted to 50 r/min and UV detection at 308 nm. Results: There was a good linearity within the range of 5.057~12.136 μg/ml for cisapride, the average recovery was 99.89% and RSD 0.29%. Conclusion: The method was simple, accurate and precise.