HPLC测定罗红霉素软胶囊的溶出度  

Determination of the Dissolution of Roxithromycin Soft Capsules by HPLC

作　　者：张传学 王建 

机构地区：[1]浙江省武义县第一人民医院药剂科,浙江武义321200 [2]浙江省食品药品检验研究院,杭州310004

出　　处：《中国现代应用药学》2013年第3期303-306,共4页Chinese Journal of Modern Applied Pharmacy

基　　金：国家药典委员会国家药品标准提高研究项目(国药典化发[2010]84号)

摘　　要：目的 采用HPLC测定罗红霉素软胶囊的溶出度。方法 以醋酸盐缓冲液（pH 5.5）为溶出介质，桨法，转速为100 r·min-1，60 min时取样，取样后采用HPLC测定。结果 罗红霉素在0.02~ 0.2 mg·mL-1内呈良好的线性关系（r=0.999 9），罗红霉素软胶囊的平均回收率为100.1％（RSD=0.6%），溶出液稳定，3批软胶囊在60 min时平均溶出度均在75%以上并且有较好的均一性。结论 该法可用于罗红霉素软胶囊溶出度的测定。OBJECTIVE To determine the dissolution of roxithromycin soft capsules by HPLC. METHODS The dissolution medium was acetate buffer （pH 5.5）. Apparatus 2 was used with 100 r·min-1. The dissolution medium was taken and analyzed by HPLC at 60 minutes. RESULTS It showed that the standard curve was linear in the range of 0.02-0.2 mg·mL-1（r=0.999 9）. The average recovery was 100.1%（RSD=0.6%） for roxithromycin soft capsules. The dissolutions of soft capsules from three batches were over 75%. CONCLUSION The established method can be used for determination of roxithromycin soft capsules dissolution.

关 键 词：罗红霉素软胶囊 溶出度 高效液相色谱法 

分 类 号：R917.4[医药卫生—药物分析学]