紫外分光光度法测定非拉尼特分散片的溶出度

Determination of dissolution of ferilnite dispersible tablet by UV spectrophotometry

目的建立测定非拉尼特分散片溶出度的方法。方法采用紫外分光光度法,以磷酸盐缓冲液(pH6.0)为溶媒,溶媒体积900 ml,转速75 r/min,15 min取样,在276 nm波长处测定其溶出度。结果非拉尼特检测浓度的线性范围为20～80μg/ml(r=0.9999);平均回收率为99.53%(RSD=0.93%),3批样品15 min溶出度均在90%以上。结论本方法简便、准确,结果可靠,可用于该制剂的溶出度测定。

Objective To establish a method for the determination of dissolution of ferilnite dispersible tablet. Methods The dissolution of ferilnite dispersible tablet was determined by UV spectrophotometry at a detection wavelength of 276 nm with phosphate buffer（pH6.0） as the solvent at a volume of 900ml. The rotation speed was 75 r/min and the sampling time was 15 min. Results The method showed a good linear relationship in the range of 20 - 80ug/ml （ r = 0. 9999）. The average recovery was 99.53% （ RSD = 0.93% ）. The dissolution of 3 batches of samples in 15 rain were above 90%. Conclusions The method is simple, accurate,and reliable, and it can be used for the determination of the dissolution of ferilnite dispersible tablet.