高效液相色谱法测定利培酮片剂的溶出度  

Determination of dissolution of resperidone tablets by HPLC

作　　者：陈钧[1] 高小玲[1] 蒋新国[1] 

机构地区：[1]复旦大学药学院,上海200032

出　　处：《中国现代应用药学》2006年第1期62-64,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立高效液相色谱法测定利培酮片的溶出度。方法按中国药典2000年版二部溶出度测定法第一法进行溶出试验，高效液相色谱法测定利培酮浓度。结果在0．2～2．41μg·mL^-1浓度内，线性关系良好r=0．9998；检测限为0．4ng；平均回收率为100．13％，RSD为1．39％（n=18）；主药在溶出介质中5d内稳定。结论该方法灵敏度高、简便易行、结果准确，适用于利培酮片剂的溶出度测定。OBJECTIVE To establish an HPLC method for the determination of dissolution of resperidone tablets. METHODS Chinese Pharmacopoeia （2000） dissolution method I was used and HPLC was adopted for the determination. RESULTS There was a good linear relationship within the concentration range of 0.2 - 2.4μg · mL^-1; the limit of detection was 0.4ng; the average recovery was 100. 13% （ RSD = 1.39% ,n= 18） and resperidone was stable in the dissolution media within 5 days. CONCLUSION This method proved to be selective, sensitive, simple and accurate for determination of dissolution of resperidone tablets.

关 键 词：利培酮 溶出度 高效液相色谱法 

分 类 号：R917.400.1[医药卫生—药物分析学]