尼麦角林分散片体外溶出度测定方法的建立

目的建立尼麦角林分散片体外溶出度的测定方法。方法采用桨法,以0.1mol/L-1盐酸溶液作为溶出介质,转速为50r/min;以紫外分光光度法测定尼麦角林的溶出量,测定波长为288nm。结果尼麦角林分在4.96～49.60μg/ml与吸光度线性关系良好(r=0.9999,n=6),平均回收率为100.08%(RSD=0.86%,n=9);3批样品在20min时累积溶出度均大于90%,RSD小于5%(n=6)。结论该方法简便、重现性好,可作为尼麦角林分散片溶出度的测定方法。

Establishment of methods for dissolution determination of Nicergoline dispersible tablets in Vitro

Objective To establish a method to determine the dissolution of dispersible tablets in Vitro.Methods The paddle method was applied,using 0.1 moloL-1hydrochloric acid solution as solvent and rotating speed of 50 romin-1.The content was determined by UV spectrophotometry with detection wavelength of 288 nm.Results There was a good linear relationship between the absorbance and the concentration in the range of 4.96~49.60μgomL-1(r= 0.9999,n=6).The average recovery was 100.08%(RSD=0.86%,n=9).The dissolutions of 3 batches of samples were all above 90%(RSD<5%,n=6) in 20 min.Conclusions The method is simple,reproducible and suitable for the determination of dissolution of Nicergoline dispersible tablets.