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HPLC法测定氨氯地平缬沙坦片中D-缬沙坦的含量
引用本文:管宜河,于小红.HPLC法测定氨氯地平缬沙坦片中D-缬沙坦的含量[J].中国药师,2010,13(8):1143-1144.
作者姓名:管宜河  于小红
作者单位:浙江尖峰海洲制药有限公司,浙江台州317016
摘    要:目的:建立测定氨氯地平缬沙坦片中D-缬沙坦含量的方法。方法:采用CHIRALPAK ADH(250mm×4.6mm,5μm)色谱柱,流动相为正己烷:异丙醇:三氟乙酸:二乙胺=780:220:1:1,流速0.5ml·min^-1,进样量10μl,检测波长230nm,柱温30℃。结果:D-缬沙坦在2.5~7.5μg·ml^-1范围内线性关系良好(r=0.9994),加样回收率为99.30%,RSD=2.93%,D-缬沙坦的检测限0.4μg·ml^-1。结论:该方法能够较好地控制氨氯地平缬沙坦片中D-缬沙坦的含量。

关 键 词:氨氯地平缬沙坦片  D-缬沙坦  HPLC

Determination the Content of D-valsartan in Amlodipine/Valsartan Tablets by HPLC
Guan Yihe,Yu Xiaohong.Determination the Content of D-valsartan in Amlodipine/Valsartan Tablets by HPLC[J].China Pharmacist,2010,13(8):1143-1144.
Authors:Guan Yihe  Yu Xiaohong
Affiliation:( Zhejiang Jianfeng Haizhou Pharmaceutical Co. , Ltd,Zhejiang Taizhou 317016, China)
Abstract:Objective: To establish a method to control the assay of D-valsartan in Amlodipine/Valsartan tablets. Method: The CHIRALPAK ADH(250 mm× 4. 6 mm,5μm) column was used, with a mobile phase was hexane: isopropanol: trifluoroacetic acid: diethylamine (780: 220: 1:1 ) and the flow rate was 0. 5 μg· ml^-1 at the detection wavelength of 230 nm. Result: The calibration curve of D-valsartan was linear in the concentration range of 2. 5-7.5 μg· ml^-1 ( r = 0. 999 4). The average recoveries were 99. 30% , RSD = 2. 93 %. The LOQ of D-valsartan was 0. 4μg· ml^-1. Conclusion: The method is able to control the assay of D-valsartan in Amlodipine/ Valsartan tablets.
Keywords:Amlodipine/Valsartan tablets  D-valsartan  HPLC
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