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
出处
《中国药房》
CAS
CSCD
2003年第7期401-403,共3页
China Pharmacy
