盐酸地芬尼多片溶出度测定法的实验研究  

Dissolution of difenidol hydrochloride tablets

作　　者：郑金凤[1] 杨汉初[1] 

机构地区：[1]湖南省药品检验所,长沙410001

出　　处：《中南药学》2005年第2期103-104,共2页Central South Pharmacy

摘　　要：目的建立盐酸地芬尼多片的溶出度测定法.方法按照中国药典2000年版二部溶出度测定方法第二法,以水900 mL为溶出介质,转速为50 r·min-1,溶出液采用HPLC法测定盐酸地芬尼多的浓度.HPLC法中选用DiamonsilTM C18柱(200 mm×4.6 mm,5 μm),以甲醇-0.5%三乙胺溶液(用磷酸调节pH至4.0)(60:40,v/v)为流动相,检测波长为220 nm.结果该方法线性范围为6.88～68.80 μg·mL-1,回收率为99.61%,RSD为0.6%(n=9).结论本法简便、准确,为中国药典2005年版建立盐酸地芬尼多片溶出度测定方法提供了依据.OBJECTIVE To study the dissolution of difenidol hydrochloride tablets. METHODS After referring to china pharmacopoeia(2000),Appendix X CⅡ,900 mL water was used as dissolution medium and apparatus of 50 r·min -1.We used HPLC method to determine the dissolution of difenidol hydrochloride tablets. In this HPLC method Diamonsil TM C_ 18(4.6 mm×200 mm,5 μm)was used as the stationary phase,methanol-0.5% triethylamine solution(pH 4.0)(60∶40,v/v)as the mobile phase and the detection wavelength of 220 nm were adopted. RESULTS The linear range was 6.88～68.80 μg·mL -1.The recovery was 99.61% with RSD of 0.6%(n=9). CONCLUSIONS This method is simple and accurate. It provides reference for China pharmacopoeia(2005)to set the standard for the dissolution of difenidol hydrochloride tablets.

关 键 词：盐酸地芬尼多片 溶出度 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]