盐酸雷尼替丁胶囊溶出度检查方法研究

Study on Dissolution Method of Ranitidine Hydrochloride Capsule

目的:建立盐酸雷尼替丁胶囊的溶出度检查方法。方法:照《中国药典》2010年版二部溶出度测定第一法,以水900ml为溶出介质,转速为100r·min-1,45min取样,用紫外-可见分光光度计测定溶出量,检测波长为314nm。结果:盐酸雷尼替丁在4.99μg·ml-1～24.96μg·ml-1浓度范围内溶液浓度与吸光度线性关系良好(r=0.9994);平均加样回收率为97.3%(n=6,RSD为0.8%)。结论:本方法简便合理、准确可靠,可用于盐酸雷尼替丁胶囊溶出度质量控制。

Objective： To establish a method for the determination of dissolution of Ranitidine Hydrochloride Capsule. Methods：Using Apparatus II of dissolution test method of Chp 2010 edition vol II, dissolution medium was water （900ml）, and rotation speed was 100r , rain-1. After 45min the dissolution solution was taken and analyzed bu UV method at the wavelength of 314nm. Results and Conclusion：The method was convenient and accurate,It can be usedy as a method of quality control.