依巴斯汀分散片溶出度测定

目的：建立依巴斯汀分散片溶出度测定方法。方法：参照《中国药典》2005年版二部溶出度测定法第二法，以0．1mol·L^-1盐酸溶液为溶出介质，20min取样，采用uV法在258nm处测定吸光度，计算溶出量。结果：依巴斯汀在3．84～14．53μg·ml^-1范围内溶液浓度与吸光度呈良好线性关系（r=0．9999）；平均回收率为99．1％（n=9，RSD为0．8％）；测定溶液在8h内稳定；样品的溶出均一性良好，RSD为3．4％～5．8％，20min时平均累积溶出率为80．0％～86．1％。结论：该方法简便易行，准确可靠，可用于依巴斯汀分散片溶出度测定。

Determination the Dissolution of Ebastine Dispersible Tablets

Objective： To establish a method for determination the dissolution of ebastine dispersible tablets. Method： Apparatus 11 of dissolution test method of Ch P 2005 edition vol Ⅱ was used ; thedissolution medium was 0. 1 mol. L^-1 hydrochiorie acid solution. After 20 min, the dissolution solution was taken and analyzed by UV method at wavelength of 258nm. Result： The linear range of ebastine was 3.84 - 14.53 μg.ml^-1 （ r = 0. 999 9 ）. the mean recovery was 99.1% with RSD of 0.8 % （ n = 9 ）. the dissolution solution was stable within 8 hours, the result showed that the mean dissolution of ebastine dispersible tablets was 80.0% - 86.1% , and the dissolution uniformity was good with RSD 3.4% -5.8%. Conclusion： The method is simple, practicable and accurate, it can be for used determination the dissolution of ebastine dispersible tablets.