HPLC法测定坎地沙坦西酯片中坎地沙坦西酯的含量  

Determination of candesartan cilexetil in candesartan cilexetil tablets by HPLC

作　　者：刘家池[1] 马俊[2] 周玲洁[1] 陈钧[1] 

机构地区：[1]复旦大学药学院药物分析教研室,上海201203 [2]上海市徐汇区中心医院药剂科,上海200031

出　　处：《中国临床药学杂志》2010年第1期39-41,共3页Chinese Journal of Clinical Pharmacy

摘　　要：目的建立用于测定坎地沙坦西酯含量的HPLC法。方法采用DIKMA C_(18)(200 mm×4.6 mm,5μm)色谱柱;流动相:10 mmol·L^(-1)磷酸二氢钾(pH 2.5)-乙腈(35:65,V/V);流速1.2 mL·min^(-1);检测波长254 nm。结果坎地沙坦西酯质量浓度的线性范围为1～200mg·L^(-1)(r=0.999 9),平均回收率100.03%,精密度RSD<1.0%,3批样品的含量分别为100.71%、101.27%、101.81%。结论本方法操作简便、快捷,结果准确、可靠,可用于坎地沙坦西酯片的质量控制。AIM To establish a method for the determination of the content of candesartan cilexetil in eandesartan cilexetil tablets by HPLC. METHODS A DIKMA C18（200 mm×4.6 mm,5μm） column was used. The mobile phase was 10 mmol·L^-1 potassium dihydrogen phosphate（pH 2.5） - acetonitrile（35：65, V/V）. The flow rate was 1.2 mL·min^-1 and the detection wavelength was 254 nm. RESULTS The HPLC standard curve was linear within the concentration range of 1 - 200 mg·L^-1 （ r = 0.999 9）. A mean recovery of candesartan cilexetil was 100.03 % with the RSD less than 1.0%. The contents of candesartan cilexetil in the tablets were 100.71%, 101.27% and 101.81% respectively in three batches compared to labeled contents. CONCLUSION The quality control method of candesartan cilexetil is accurate and stable. It can be used for the quality appraisal of candesartan cilexetil tablets.

关 键 词：坎地沙坦西酯片 高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学]