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反相高效液相色谱法测定氨氯缬沙噻嗪片中3种组分的溶出度
引用本文:何晓燕,谢赞,白敏,赫玉霞,陈玉洁. 反相高效液相色谱法测定氨氯缬沙噻嗪片中3种组分的溶出度[J]. 中国新药杂志, 2012, 0(15): 1740-1742,1755
作者姓名:何晓燕  谢赞  白敏  赫玉霞  陈玉洁
作者单位:石药集团药物研究院
基金项目:国家十一五“重大新药创制”科技重大专项(2011ZX09401-306)
摘    要:目的:建立可同时测定氨氯缬沙噻嗪片3种组分溶出度的反相高效液相色谱方法。方法:采用Inertsil ODS-3 C18色谱柱(250 mm×4.6 mm,5μm),以20 mmol.L-1磷酸二氢钾溶液(磷酸调节pH值至3.5)-乙腈(55∶45)为流动相,流速1.0 mL.min-1,检测波长225 nm。结果:氨氯地平、缬沙坦和氢氯噻嗪的线性范围分别为1.3~20.1μg.mL-1(r=0.999 9),39.8~636.8μg.mL-1(r=0.999 9)和3.1~49.4μg.mL-1(r=1.000 0);回收率分别为100.5%,100.6%和100.4%。结论:方法简便快速、重复性好,可用于同时测定氨氯缬沙噻嗪片3种组分的溶出度。

关 键 词:氨氯地平  缬沙坦  氢氯噻嗪  高效液相色谱法  溶出度

Simultaneous HPLC determination of the dissolution of three components in compound amlodipine-valsartan-hydrochlorothiazide tablets
HE Xiao-yan,XIE Zan,BAI Min,HE Yu-xia,CHEN Yu-jie. Simultaneous HPLC determination of the dissolution of three components in compound amlodipine-valsartan-hydrochlorothiazide tablets[J]. Chinese Journal of New Drugs, 2012, 0(15): 1740-1742,1755
Authors:HE Xiao-yan  XIE Zan  BAI Min  HE Yu-xia  CHEN Yu-jie
Affiliation:(CSPC Institute of Pharmaceutical Research,Shijiazhuang 050051,China)
Abstract:Objective: To develop an HPLC method for simultaneous determination of dissolution of amlodipine-valsartan-hydrochlorothiazide tablets.Methods: The method was achieved on an Inertsil ODS-3 C18 column(250 mm×4.6 mm,5 μm),using a mixture of potassium dihydrogen phosphate solution(adjust to pH 3.5 with H3PO4)-acetonitrile(55∶45) as the mobile phase.The flow rate was 1.0 mL·min-1 and UV detection was at 225 nm.Results: The calibration curves of amlodipine,valsartan and hydrochlorothiazide were linear in the range of 1.3~20.1 μg·mL-1(r=0.999 9),39.8~636.8 μg·mL-1(r=0.999 9) and 3.1~49.4 μg·mL-1(r=1.000 0),respectively.The average recoveries were 100.5%,100.6% and 100.4%,respectively.Conclusion: The established method is simple,rapid and reproducible for simultaneous determination of dissolution of amlodipine-valsartan-hydrochlorothiazide tablets.
Keywords:amlodipine  valsartan  hydrochlorothiazide  HPLC  dissolution
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