微乳液相色谱法测定厄贝沙坦片中厄贝沙坦的含量及有关物质  

Determination of irbesartan tablets and related substances by microemulsion liquid chromatography

作　　者：郑艾妮 王柳云[1] 余诺君 李宁[1] 

机构地区：[1]广东药科大学药学院,广东广州510006

出　　处：《广东药学院学报》2016年第4期444-448,共5页Academic Journal of Guangdong College of Pharmacy

基　　金：国家自然科学基金(81173525)

摘　　要：目的建立一种微乳液相色谱法测定厄贝沙坦片的质量分数及有关物质。方法采用Agela technologies odyssil C18柱（4.6 mm×250 mm,5μm）,以SDS-正丁醇-环己烷-水（质量比3.0∶6.0∶0.8∶92.2）为流动相,柱温30℃,流速1.0 m L/min,进样量20μL,检测波长230 nm。结果有关物质与主要成分可以完全分离。厄贝沙坦在50.01-175.04μg/m L范围内与峰面积线性关系良好（r=0.999 2,n=6）,检测限为0.02μg/m L,平均回收率为100.4%（RSD=1.0%,n=9）。有关物质在0.075 3-0.351 8μg/m L范围内呈线性,检测限为0.025μg/m L,平均回收率为100.5%（RSD=1.1%,n=9）。2个规格的厄贝沙坦片中厄贝沙坦的平均质量分数分别为99.4%和99.8%。结论建立的微乳液相色谱法检测厄贝沙坦及相关物质快速、准确、重复性好且绿色环保,减少了有机溶剂的使用。Objective A microemulsion liquid chromatography method was developed for the determination of irbesartan and related substances in tablets.Methods Chromatographic separation was performed on a Agela technologies odyssil C18（ 4.6 mm× 250 mm,5 μm） at the column temperature of 30 ℃.The mobile phase was SDS-butylalcohol-cyclohexane-water（ 3.0 ∶6.0 ∶0.8 ∶ 92.2） at a flow-rate of 1.0 m L/min and the injection volume was 20 μL.The detection wavelength was 230 nm.Results Related substances were completely separated from the major constituents.In the range of 50.01 to 175.04 μg/m L（ r = 0.999 2,n =6）,it has a good linear relationship for irbesartan with the peak area.The average recovery of irbesartan was100.4%（ RSD = 1.0%,n = 9） and it＇s detection limit was 0.02 μg/m L.While the related compound A was linear over the range of 0.075 3- 0.351 8 μg/m L,with a detection limit of 0.025 μg/m L and it＇ s average recovery was 100.5%（ RSD = 1.1%, n = 9）.The contents of 2 specifications were 99.4% and 99.8%,respectively.Conclusion A rapid,accurate and reproducible determination method of irbesartan and related substances with microemulsion liquid chromatography was established.It was green and environmental,and could reduce the use of organic solvents.

关 键 词：厄贝沙坦片 微乳液相色谱法 厄贝沙坦 有关物质 

分 类 号：R927.2[医药卫生—药学]