厄贝沙坦胶囊溶出度测定方法的改进

Improvement of Dissolution Determination of Irbesartan Capsules

目的:建立厄贝沙坦胶囊的溶出度测定方法。方法:照溶出度测定法(《中国药典》2010年版二部附录XC第一法),以0.1 mol·L^(-1)盐酸溶液为溶剂,转速为100 r·min^(-1);紫外分光光度法测定,测定波长为245 nm。结果:30 min内产品的溶出率达到75%以上,辅料对主药测定无干扰,厄贝沙坦线性范围为2.50~25.00μg·ml^(-1)(r=0.999 9),回收率为100.5%(RSD=0.13%,n=9)。结论:本法操作简便、准确可靠,适用于厄贝沙坦胶囊的溶出度测定。

Objective：To develop a method for the dissolution determination of irbesartan capsules.Method：According to the dissolution test[Pharmacopoeia of the People’s Republic of China（2010 Edition,Volume 2,Supplemental method I）],0.1 mol· L-1 hydrochloric acid was used as the solvent,the rotation speed was 100 r ？ min-1,and the detection wavelength was at 245 nm.Result：The dissolution of irbesartan capsules was above 75%in 30 min.The excipients showed no interference with the determination. The calibration curve was linear within the range of 2.50-25.00 μg·ml-1（r =0.999 9）.The average recovery was 100.5%（RSD = 0.13%,n =9）.Conclusion：The method is simple,accurate and precise,and can be applied in the dissolution determination of irbesartan capsules.