紫外分光光度法测定六甲蜜胺片及胶囊的溶出度  

Dissolution Test of Altretamine Tablets and Altretamine Capsules by UV Spectrophotometry

作　　者：王昕[1] 赵喆[1] 左文坚[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《中国药品标准》2006年第1期34-36,共3页Drug Standards of China

摘　　要：目的：建立紫外分光光度法测定六甲蜜胺片及胶囊的溶出度。方法：照中国药典2000年版(二部)溶出度测定第一法,六甲蜜胺片剂及胶囊剂分别以盐酸溶液(0.9→10000)及盐酸溶液(9→10000)900ml为溶出介质,转速均为100r·min^(-1),30min时取样,紫外分光光度法检测波长为241nm,测定六甲蜜胺片及胶囊的溶出度。结果：紫外分光光度法测定六甲蜜胺的线性范围为1.27～8.48μg·mL^(-1)(r=0.9999),规格为50mg和100mg的六甲蜜胺片的平均回收率分别为100.6%和101.1%,RSD分别为0.63%(n=9)和0.18%(n=6)；六甲蜜胺胶囊的平均回收率为99.1%,RSD为0.31%,(n=6)。结论：该方法简便、易行,结果准确。Objective ：A UV method was established for detecting dissolution of Altretamine Tablets ad Altretamine Capsules. Methods： Using Apparatus Ⅰ of dissolution test method of ChP 2000 edition vol Ⅱ , dissolution medium of Altretamine Tablets and Altretamine Capsules were hydrochloric acid solution （0.9→10000）and hydrochloric acid solution （9→10000）, respectively with rotating speed at 100r · min^-1. After 30 min the dissolution solution of the tablets and capsules were taken and analyzed by UV method at wavelength of 241nm. Results：The linear range was 1.27～8.48μg · mL^-l（r=0. 9999）. The mean recovery of Altretamine Tablets（50mg and 100mg）were 100.6% and 101.1% with RSD 0.63%（n=9） and 0. 18%（n=6）; The mean recovery of Altreramine Capsules was 99.1% with RSD 0. 31% （n=6）. Conclusion ：The method was simple ,practicable and accurate.

关 键 词：紫外分光光度法 六甲蛮胺片及胶囊 溶出度 

分 类 号：R927.2[医药卫生—药学] R927.11