HPLC法测定复方氨氯地平缬沙坦片有关物质  

Determination of Related Substances in Compound Amlodipine and Valsartan Tablets by HPLC

作　　者：魏春燕[1] 沈利[1] 王延松[1] 姜亚莉[2] 

机构地区：[1]扬子江药业集团有限公司药物研究院,江苏泰州225321 [2]扬州市第一人民医院药剂科

出　　处：《中国药师》2011年第8期1142-1144,共3页China Pharmacist

摘　　要：目的:建立测定复方氨氯地平缬沙坦片有关物质的HPLC方法。方法:用Agilent Extend C_(18)(250mm×4.6mm,5μm)色谱柱,以0.01mol·L^(-1)磷酸二氢钾溶液(pH 3.5)-(甲醇:乙腈=10:40)为流动相,梯度洗脱,流速1.0ml·min^(-1),柱温40℃,检测波长250nm,进样量20μl。结果:有关物质各杂质峰与主峰之间的分离良好,且已知单个杂质分离良好。结论:该方法准确可靠,专属性强,可用于复方氨氯地平缬沙坦片有关物质测定。Objective：To establish an HPLC method for the determination of related substances in compound amlodipine and valsartan tablets.Method：Agilent Extend C18column（250 mm×4.6 mm,5μm）was used with 0.01 mol·L^-1KH2PO4 buffer（pH 3.5）-methanol：acetronitrile of 10：40 as the mobile phase with gradient elution at a flow rate of 1.0 ml·min^-1.The column temperature was 40℃and the detection wavelength was 250 nm.Injection volume was 20μl.Result：Amlodipine,valsartan and their related substances could be well separated.Conclusion：This method is accurate,specific and sensitive,and can be used for the determination of related substances in compound amlodipine and valsartan tablets.

关 键 词：复方氨氯地平缬沙坦片 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]