Baaske D M, Karnatz N N, Carter J E
J Pharm Sci. 1983 Feb;72(2):194-6. doi: 10.1002/jps.2600720226.
A high-performance liquid chromatographic method for determining the concentration of mononitroglycerins and dinitroglycerins in the commonly used pharmaceutical raw material nitroglycerin (10% w/w) on lactose USP is presented. A coefficient of variation of less than 5% for the partially nitrated glycerins was achieved over the range examined (0-4.0 micrograms/mg). Thirteen lots of raw material were examined and found to contain a total of less than 0.13% w/w partially nitrated glycerins. A variable wavelength detector (lambda = 218 nm) and a microphenyl column were employed. The mobile phase was acetonitrile-water (36:64) pumped at 2 ml/min. The internal standard was isosorbide dinitrate. Total analysis time was 12 min.
本文介绍了一种高效液相色谱法，用于测定乳糖USP上常用药物原料硝酸甘油（10%w/w）中一硝酸甘油酯和二硝酸甘油酯的浓度。在所研究的范围内（0 - 4.0微克/毫克），部分硝化甘油的变异系数小于5%。对13批原料进行了检测，发现其中部分硝化甘油的总含量低于0.13%w/w。使用了可变波长检测器（λ = 218纳米）和微苯基柱。流动相为乙腈 - 水（36:64），流速为2毫升/分钟。内标为二硝酸异山梨酯。总分析时间为12分钟。
