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高效液相色谱法测定软膏中1,2,3-三硝氧基丙烷及其杂质:(2RS)-3-羟基丙烷-1,2-二硝氧基和2-羟基丙烷-1,3-二硝氧基

The HPLC determination of propane-1,2,3-triyl trinitrite and impurities: (2RS)-3-hydroxypropane-1,2-diyl dinitrate and 2-hydroxypropane-1,3-diyl dinitrate in ointment.

作者信息

Krzek Jan, Moniczewska Maria, Zabierowska-Slusarczyk Grazyna

机构信息

Department of Inorganic and Analytical Chemistry, Collegium Medicum, Jagiellonian University Cracow, 9 Medyczna Street, 30 688 Cracow, Poland.

出版信息

J Pharm Biomed Anal. 2003 Oct 15;33(3):403-9. doi: 10.1016/s0731-7085(03)00242-5.

Abstract

A HPLC method for determination of propane-1,2,3-triyl trinitrate and impurities: (2RS)-3-hydroxypropane-1,2-diyl dinitrate and 2-hydroxypropane-1,3-diyl dinitrate ointment was developed. The conditions for good separation of constituents, while avoiding vehiculum interference were established. The results feature of high accuracy and good precision. For individual constituents R.S.D. is ranged from 0.7 to 9.9%, while recovery was 100.1% for propane-1,2,3-triyl trinitrate and 95.1-99.0% for impurities. It has been found that propane-1,2,3-triyl trinitrate used in medicine in the form of ointment contains such impurities which can be identified and quantified at relatively low concentrations of 70 ng ml(-1).

摘要

建立了一种测定三硝酸甘油酯及其杂质((2RS)-3-羟基丙-1,2-二醇二硝酸酯和2-羟基丙-1,3-二醇二硝酸酯)软膏的高效液相色谱法。确定了成分良好分离且避免基质干扰的条件。结果具有高准确度和良好精密度。各成分的相对标准偏差在0.7%至9.9%之间,三硝酸甘油酯的回收率为100.1%,杂质的回收率为95.1%至99.0%。已发现药用软膏形式的三硝酸甘油酯含有此类杂质,在相对低至70 ng/ml的浓度下即可进行鉴定和定量。

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