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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
【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.
【Key words】 candesartan cilexetil tablet; HPLC; content determination;
- 【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