摘要
目的 建立克拉霉素颗粒溶出度的测定方法.方法 以醋酸盐缓冲液（pH =5.0）为溶出介质,溶出30 min,采用高效液相色谱法进行测定.结果 克拉霉素质量浓度在20.60～92.68μg/mL范围内与峰面积呈良好线性关系.线性回归方程为A=1.9987C＋0.1521,r=0.999 3（n =8）.结论 该方法简单、快速、准确,适用于克拉霉素颗粒的溶出度测定.
Objective To establish a method for the dissolution determination of Clarithromycin Granules.Methods With acetate buffer solution（pH =5.0） as the dissolution medium and the dissolution time of 30 rmin,the determination was performed by high performance liquid chromatography（HPLC）.Results The linear range of clarithromycin was 20.60-92.68 μg/mL,the linear equation is A =1.998 7 C ＋ 0.152 1,r =0.999 3（n =8）.Conclusion The tnethod is simple,fast,accurate and can be applied to determine the dissolution of Clarithromycin Granules.
出处
《中国药业》
CAS
2014年第5期27-28,共2页
China Pharmaceuticals
基金
国家重大科学仪器设备开发专项
项目编号:2012YQ180132
关键词
克拉霉素颗粒
溶出度
高效液相色谱法
Clarithromycin Granules
dissolution
high performance liquid chromatography
