吲达帕胺片溶出度检查方法研究  

Study on Dissolution Method of Indapamide Tablets

作　　者：赵喆[1] 唐素芳[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》2010年第4期271-274,共4页Drug Standards of China

摘　　要：目的：建立吲达帕胺片的溶出度检查方法。方法：照《中国药》典2005年版二部溶出度测定第一法，以磷酸盐缓冲溶液（pH6．8）900mL为溶出介质，转速为100r·min^-1，45min取样，用紫外一可见分光光度法测定溶出量，检测波长为240nm。结果：吲达帕胺在0．141～3．373μg·mL^-1浓度范围内溶液浓度与吸光度线性关系良好（r=0．9997）；平均回收率：糖衣片为99．1％（n=9，RSD为0．68％），薄膜衣片为99．5％（n=9，RSD为0．99％）。结论：本方法简便合理、准确可靠，可用于吲达帕胺片溶出度质量控制。Objective： To establish a method for the determination of the dissolution of Indapamide Tablets. Method： Using Apparatus Ⅱ of dissolution test method of Chp 2005 edition vol Ⅱ , dissolution medium was phosphate buffer solution （ pH 6. 8 ）, and rotation speed was 100 r· min^-1. After 45 min the dissolution solution was taken and analyzed by UV method at the wavelength of 240 nm . Results：The linear relationship was in the range of 0. 141 -3. 373 μg · mL^-1 （r = 0. 999 7 ） , the average recoveries were obtained ： Sugar coated tablets was 99. 1% （n =9,RSD =0. 68% ） ; Film coated tablets was 99. 5% （n =9,RSD =0. 99% ）. Conclusion：The method was convenient and accurate. It can be used as a method of quality control.

关 键 词：吲达帕胺片 溶出度 

分 类 号：R972.4[医药卫生—药品]