单硝酸异山梨酯择时微孔渗透泵片的制备及含量测定  

Preparation and content determination of isosorbide mononitrate timing microporous osmotic pump tablets

作　　者：邹青 全海燕 李平 ZOU Qing;QUAN Haiyan;LI Ping(Hunan Polytechnic of Environment and Biology,Hunan,Hengyang 421000,China)

机构地区：[1]湖南环境生物职业技术学院,湖南衡阳421000

出　　处：《中国医药科学》2020年第13期52-54,72,共4页China Medicine And Pharmacy

基　　金：湖南环境生物职业技术学院青年基金项目(ZK2019-02)。

摘　　要：目的建立单硝酸异山梨酯择时微孔渗透泵片中单硝酸异山梨酯的高效液相色谱含量测定方法。方法采用Beckman ODS色谱柱(4.6mm×25cm,5μm),以甲醇-水=40∶60(v/v)为流动相,流速为1.0mL/min,检测波长为219nm,进样量20μL。结果在此色谱条件下,单硝酸异山梨酯浓度与峰面积在5.0~50μg/mL范围内线性关系良好,r=0.9999,平均回收率为99.19%,RSD为0.41%(n=9)。结论本方法灵敏度较高,检测快速准确,可用于单硝酸异山梨酯择时微孔渗透泵片的质量控制。Objective To establish a high performance liquid chromatography(HPLC)method for the determination of isosorbide mononitrate(ISMN)in ISMN timing microporous osmotic pump tablets.Methods Beckman ODS column(4.6mm×25cm,5μm)was used with methanol-water ratio of 40∶60(v/v)as mobile phase,with a flow rate of 1.0mL/min,with a detection wavelength of 219nm,and an injection volume of 20μL.Results Under this chromatographic condition,the linear relationship between ISMN concentration and peak area was good in the range of 5.0-50μg/mL,r=0.9999,the average recovery rate was 99.19%,and RSD was 0.41%(n=9).Conclusion The method is highly sensitive,rapid and accurate in test,and it can be used for quality control of ISMN timing microporous osmotic pump tablets.

关 键 词：单硝酸异山梨酯 择时 微孔渗透泵 含量测定 高效液相色谱 

分 类 号：R927.2[医药卫生—药学]