HPLC法测定甲磺酸溴隐亭片的含量、含量均匀度及其溶出度  

Determination of Content,Uniformity and Dissolution of Bromocriptine Mesylate Tablets

作　　者：黄剑英[1] 郑淑凤[1] 叶飞云[1] 

机构地区：[1]厦门市药品检验所,厦门361012

出　　处：《中国药品标准》2006年第1期29-32,共4页Drug Standards of China

摘　　要：目的测定甲磺酸溴隐亭片的含量,含量均匀度及溶出度。方法；采用C_(18)色谱柱,流动相为0.1%碳酸铵溶液-乙腈(35∶65),检测波长300nm。溶出度以转篮法测定。转速120r·min^(-1),溶出介质为0.1mol/L盐酸溶液500ml。结果在59.66～477.28μg·ml^(-1)(r=0.99995 n=5)及1.802～9.01μg·ml^(-1)(r=0.9999 n=5)内线性良好；平均回收率分别为100.02%,(n =5 RSD为0.8%)、99.21%(n=5 RSD为0.6%)。片剂60min取样,主药溶出80%以上。结论：方法简便、准确、专属性强。可作为该制剂的含量测定和质量控制方法。Objective ： To determine the content,uniformity and dissolution of Bromocriptine Mesylate Tables. Methods：A C18 column was used, with mobile phase of 0. 1% ammonium carbonate-acetonitrile （35 ： 65）. The detection wavelength was 300nm. Basket Method was used to determine the dissolution. The rotation speed was 120r. min^-1 and the dissolution medium was 500ml of 0. 1mol · L^-1 hydrochloric acid solution. Results：The linear range of the standard curve were 59. 66～477. 28μg ·ml^4（r=0.99995,n=5）and 1.802～9.01μg·ml^-1（r=.9999 n=5）;The average recovery of the assay were 100.02% with a relative standard deviation of 0.8%（n=5） and 99.21% with a relative standard deviation of 0.6% （n=5） .The drug dissolution at 60min was above 80%.Conclusion：This method is convenient ,accurate specific for the quatily control of Bromocriptine Mesylate Tablets.

关 键 词：甲磺酸溴隐亭片 HPLC 含量测定 含量均匀度 溶出度 

分 类 号：R971[医药卫生—药品] R927.2[医药卫生—药学]