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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

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【作者】 刘家池马俊周玲洁陈钧

【Author】 LIU Jiachi~1,MA Jun~2,ZHOU Lingjie~1,CHEN Jun~1(1 Department of Pharmaceutical Analysis,School of Pharmacy, Fudan University,Shanghai 201203,China;2 Department of Pharmacy,Xuhui District Central Hospital,Shanghai 200031,China)

【机构】 复旦大学药学院药物分析教研室上海市徐汇区中心医院药剂科

【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 C18(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。

【Abstract】 AIM To establish a method for the determination of the content of candesartan cilexetil in candesartan cilexetil tablets by HPLC.METHODS A DIKMA C18(200 mm x 4.6 mm,50μm) 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.

  • 【文献出处】 中国临床药学杂志 ,Chinese Journal of Clinical Pharmacy , 编辑部邮箱 ,2010年01期
  • 【分类号】R927.2
  • 【下载频次】92
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