杨爽,汪磊,朱萌,任鑫霞,罗春丽,何仲贵
YANG Shuang1,WANG Lei2,ZHU Meng1,REN Xin-xia1,LUO Chun-li1,HE Zhong-gui1(1.School of Pharmacy

• 1:沈阳药科大学药学院
• 2:天津市武清区药品检验所

摘要(Abstract)：

目的建立复方盐酸贝那普利片中盐酸贝那普利和苯磺酸氨氯地平含量测定的HPLC法。方法采用Diamonsil C18柱(200 mm×4.6 mm,5μm);流动相为氯化钾溶液(1 000 mL中含90 mmoL氯化钾和10 mmoL盐酸,pH值2.06)-水-甲醇(体积比为17∶25∶58),每1 000 mL流动相中加入612 mg高氯酸钠;流速为1 mL.min-1;检测波长为240 nm;柱温为35℃;进样量为20μL。结果盐酸贝那普利与苯磺酸氨氯地平可达到较好分离,盐酸贝那普利的质量浓度在10.0～200.0mg.L-1内与峰面积呈良好的线性关系(r=0.999 8);苯磺酸氨氯地平(按氨氯地平计)质量浓度在5～100 mg.L-1内与峰面积呈良好的线性关系(r=0.999 8)。盐酸贝那普利与苯磺酸氨氯地平的平均回收率分别为99.9%(n=9)和100.4%(n=9)。结论 HPLC法适用于复方盐酸贝那普利片中盐酸贝那普利和苯磺酸氨氯地平的含量测定。
Objective To establish a method for the determination of the content of compound benazepril hydrochloride tablets.Methods The determination was performed with a C18 chromatographic column.The mixed solution of potassium chloride buffer-methanol-water(V∶V∶V=17∶25∶58,adjusted pH to 2.06 by hydrochloric acid),to 1 000 mL of which was added 612 mg of sodium perchlorate,was chosen as the mobile phase;the flow rate was 1.0 mL·min-1;the detection wave length was set at 240 nm;the column temperature was 35 ℃,and the sample size was 20 μL.Results Benazepril hydrochloride could be well separated from amlodipine besylate under the conditions mentioned above.The linear relationship between the concentration and area of chromatographic peak were established in the range of 10.0-200.0 mg·L-1 for benazepril hydrochloride and in the range of 5-100 mg·L-1 for amlodipine besylate.The average recoveries of benazepril hydrochloride and amlodipine besylate were 99.9% and 100.4%(n=9),respectively.Conclusions The method is easy,exclusive,accurate and suitable for the determination of the content of compound benazepril hydrochloride tablets.

关键词(KeyWords)： 复方盐酸贝那普利片;盐酸贝那普利;苯磺酸氨氯地平;高效液相色谱法;含量测定
compound benazepril hydrochloride tablet;benazepril hydrochloride;amlodipine besylate;HPLC;content determination

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 杨爽,汪磊,朱萌,任鑫霞,罗春丽,何仲贵
YANG Shuang1,WANG Lei2,ZHU Meng1,REN Xin-xia1,LUO Chun-li1,HE Zhong-gui1(1.School of Pharmacy

DOI: 10.14066/j.cnki.cn21-1349/r.2010.09.017

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