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  

Simultaneous HPLC determination of the dissolution of three components in compound amlodipine-valsartan-hydrochlorothiazide tablets

作　　者：何晓燕[1] 谢赞[1] 白敏[1] 赫玉霞[1] 陈玉洁[1] 

机构地区：[1]石药集团药物研究院,石家庄050051

出　　处：《中国新药杂志》2012年第15期1740-1742,1755,共4页Chinese Journal of New Drugs

基　　金：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。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 C lg column （250 mm × 4.6 ram, 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 ofl. 3-20.1 μg·mL^（-1）（r =0.9999）, 39.8-636.8 μg·mL^（-1）（r =0.9999） and 3.1 -49.4 μg·mL^（-1）（r = 1. 0000） , 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 amlodip- ine-valsartan-hydrochlorothiazide tablets.

关 键 词：氨氯地平 缬沙坦 氢氯噻嗪 高效液相色谱法 溶出度 

分 类 号：R972.4[医药卫生—药品]