吲达帕胺胶囊的研制与质量控制  

Study on the Preparation and Quality Control of Indapamide Capsules

作　　者：苏乐群[1] 孙淑娟[1] 孟彦[1] 李宏建[1] 

机构地区：[1]山东省千佛山医院药剂科,济南市250014

出　　处：《中国药房》2003年第7期401-403,共3页China Pharmacy

摘　　要：目的 :研究吲达帕胺胶囊的制备及其质量控制方法。方法 :含量测定采用紫外分光光度法 ;有关物质检查采用高效液相色谱法。结果 :吲达帕胺在3 7～11 1μg/ml浓度范围内线性关系良好 ,r=0 9997,回收率为99 50% ,精密度为0 43% ;有关物质检查精密度为0 1%。考察3批样品 ,相对百分含量分别为99 07%、99 34%、99 58 % ;每批样品随机取10粒 ,所测得的含量均匀度A +1 80S值均小于15;有关物质均小于1 %。结论 :以本方法制备的吲达帕胺胶囊 ,主药和辅料混合均匀 ,含量及有关物质符合相关规定 ,质控方法可靠。OBJECTIVE:To prepare indapamide capsules and study the quality control methods METHODS:The content of indapamide in capsules was determined by UV-spectrophotometry The other ingredients were determined by HPLC RES_ULTS:The calibration curve was linear within the concentration range of 3 7～11 1μg/ml(r=0 9 997);the recovery of indapamide was 99 50%,RSD=0 43% The RSDs of indapamide and other ingredients were 0 43% and 0 1% respectively The relative percentage contents of 3 batches of sample were 99 07%,99 34%,99 58% respectively The uniformity A+1 80S of contents of indapamide in all samples detected was <15 and the content of relevant substances was <1% CONCLUSION:In the prepared capsules,the indapamide and adjuvant are mixed with uniformity,and the contents of indapamide and relevant substances are up to the standard and the method of quality control is reliable

关 键 词：吲达帕胺胶囊 质量控制 制备 紫外分光光度法 高效液相色谱法 降压药物 

分 类 号：R972.4[医药卫生—药品]