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本文应用HPLC法对硝酸甘油片中三硝酸甘油酯及其降解产物进行了含量测定和贮存期研究。模拟试验五份平均回收率为100.13%,变异系数0.80%;稳定性试验,硝酸甘油片中三硝酸甘油酯的扩散速度基本符合一级动力学反应,根据Arrhenius指数定律,计算贮存期,本品若五分之一衰期t_(0.8),在25℃时,为20天;在5℃时,为半年。实验条件:固定相YWG-C_(18)H_(37)10μm,色谱柱250×4.6mm(i.d.),流动相(1)为甲醇—水(甲醇35ml加水至100ml);流动相(2)为甲醇—水(4∶6V/V);UV205nm检测;进样量5μl。
In this paper, HPLC method was used to determine the content and storage period of glyceryl trinitrate in nitroglycerin tablets and its degradation products. The average recoveries of the five samples were 100.13% and the coefficient of variation was 0.80%. The stability test showed that the diffusion rate of glyceryl trinitrate in the nitroglycerin tablets basically corresponded to the first-order kinetic reaction. According to the Arrhenius index law, the storage period was calculated. If the one-fifth of the decline t_ (0.8), at 25 ℃, for 20 days; at 5 ℃, for six months. The experimental conditions were as follows: the mobile phase (1) was methanol-water (methanol 35ml water to 100ml); the mobile phase (2) was Methanol - water (4: 6V / V); UV205nm detection; injection volume 5μl.