盐酸氨溴索口腔崩解片的溶出度测定

Dissolution Determination of Ambroxol Hydrochloride Orally Disinegreting Tablets

目的建立盐酸氨溴索口腔崩解片的溶出度测定方法。方法以0.1 mol·L^(-1)盐酸溶液900 mL为溶出介质,转速50 r·min^(-1),采用紫外分光光度法,在244 nm波长处测定盐酸氨溴索口腔崩解片的吸收度。结果盐酸氨溴索在3.16～28.44μg·mL^(-1)浓度范围内与吸光度呈良好线性关系,回归方程为Y=0.0242X+0.0183,r=0.9993,重复性实验的RSD为0.28%,平均方法回收率为100.4%,RSD为0.77%。结论该方法简便准确可靠,可用于盐酸氨溴索口腔崩解片的溶出度测定。

Objective To establish a method for the dissolution determination of ambroxol hydrochloride orally disinegreting tablets.Methods The UV spectrophotometry was used.The detecting wavelength was at 244 nm.The liquid of dissolution was hydrochloride（0.1 mol·L -1 ）.Rotational speed was 50 r·min -1 .Results The linearity range was 3.16- 28.44 μg·mL -1 .The regression equation was Y =0.024 2 X ＋0.018 3（ r =0.999 3）.The RSD of repeatable test was 0.28%.The average recovery of methodology was 100.4% and RSD was 0.77%.Conclusion The method is simple and reliable, and can be used for the dissolution determination of ambroxol hydrochloride orally disinegreting tablets.