HPLC法同时测定复方卡托普利片中主药含量及含量均匀度  

Simultaneous Content Determination and Uniformity of Content in Compound Captopril Tablets by HPLC

作　　者：杨兴明 陈平 

机构地区：[1]武汉市药品检验所,武汉430012 [2]武汉爱民制药厂,武汉430010

出　　处：《中国药品标准》2006年第6期40-42,共3页Drug Standards of China

摘　　要：目的:建立HPLC法同时测定复方卡托普利片中卡托普利和氢氯噻嗪的含量及含量均匀度。方法:采用C18色谱柱(4.6mm×250mm,5μm),流动相为甲醇-水-磷酸(450∶550∶0.5),流速:1.0mL.min-1,检测波长:210nm,进样量为20μL,柱温:25℃。结果:卡托普利在0.044～8.80μg范围内线性关系良好,r=0.9999,平均回收率为99.4%,RSD为0.9%(n=9);氢氯噻嗪在0.016～6.57μg范围内线性关系良好,r=1.0000,平均回收率为100.5%,RSD为0.4%(n=9)。结论:方法简便灵敏、结果准确可靠,可用于该制剂的含量测定及含量均匀度检查。Objective：To establish an HPLC method for the content determination and Uniformity of content of Captopril and Hydrochlorothiazide in Compound Captopril Tablets simultaneously. Methods：C18 column（4. 6mm×250mm, 5μm）was used at 25℃. The mobile phase was methanol-water-phosphoric acid（450：550 ： 0. 5）. The flow rate was 1.0mL·min^-1. The injection volumn was 20μL and the detective wavelength was at 210nm. Results：Captopril had a good linear relationship beween 0. 044-8. 80μg（r = 0. 9999） ,the average recovery was 99.4% （n= 9） ,RSD was 0.9%. Hydrochlorothiazide had a good linear relationship beween 0. 016% 6.57μg（r =1.0000） ,the average recovery was 100. 5% （n= 9） ,RSD was 0.4%. Conclusion ：This method is sample ,sensitive ,accurate and can be used for the content determination and Uniformity of content in Compound Captopril Tablets.

关 键 词：HPLC法 复方卡托普利 含量 含量均匀度 

分 类 号：R972.4[医药卫生—药品]