布洛伪麻分散片的溶出度测定.pdfVIP

中国医药工业杂志Chinese Journal of Pharmaceuticals 2012 , 43 (1) • 43 • -，~~~，，，，~~ Z 药品分析与质控 3 ·可Cc.c.c.c.‘c.c..区c.c.c.c.c.c.c.c.c.4且 布洛伪麻分散片的溶出度测定 邱颖垣12，王铁杰2 ，周寿林2，张弘2，李清1* (1.沈阳药科大学，辽宁沈阳 lω016; 2. 深圳市药品检验所，广东深圳518057) 摘要g 建立了布洛伪麻分散片的溶出度检查方法。考察在不同的溶出介质、转速下布洛伪麻分散片中布洛芬和盐酸伪麻 黄碱的溶出情况，确定了溶出参数z 照中国药典2010 年版溶出度第二法装置，以 pH 5.5 的磷酸盐缓冲液900 ml 为溶出介 质，转速 50 r/min. 采用 HPLC 法测定每片中布洛芬和盐酸伪麻黄碱的溶出量。使用 C8 色谱柱，流动相为乙脯·水(1: 1)(每 1000 ml 含十二炕基磺酸销2.5 g，加磷酸 1 ml，混匀后用氨水调至 pH 3.2) ，检测波长215 nm。布洛芬和盐酸伪 麻黄碱在 10-1 ∞0μg/ml 和1.5 - 150μg/ml 范围内线性关系良好，回收率为 98.1%和 100.4% ， RSD 为 2.6%和 0.4%。 关键词z 布洛伪麻分散片:布洛芬:盐酸伪麻黄碱:溶出度:高效液相色谱:测定 中图分类号: R917; 0657.7+2 文献标志码:A 文章编号: 1001-8255 (2012)01-0043-04 Determination of Dissolution of Ibuprofen and Pseudoephedrine Hydrochloride Dispersible Tablets l 2 2 2 QIU Yingheng 气 WANG Tiejie , ZHOU Shoulin , ZHANG Hong , LI Qingl* (1. Shenyang Pharmaceutical University, Shenyang 100016; 2. Shenzhen Institutefor Drug Control, Shenzhen 518057) ABSTRACT: The dissolubilities of ibuprofen and pseudoephedrine hydrochloride dispersible tablets in different dissolution mediums and different rotation speeds were discussed. The dissolution method was determined as follows: using the second dissolution method in Chinese Pharmacopoeia 2010 edition, at the rotation speed of 50 r/min and with the phosphate buffer solution (pH 5.5) of 900 m l. Ibuprofen and pseudoephedrine hydrochloride were detemined by HPLC. A C I8 column was used with the mobile phase of acetonitrile-water (1 : 1) (containing sodium dodecyl sulfate 2.5 g and phosphoric acid 1 ml dissolved in 1 000 ml , adju