硝酸异山梨酯类药品理化常数与分离定量的研究

Studies on Determination of Physical and Chemical Constants and Separation as well as Quantification of Isosorbide Nitrates

本研究报导了硝酸异山梨酯、５－单硝酸异山梨酯、２－单硝酸异山梨酯理化常数测试，ＴＬＣ法对相关物质的分离及ＨＰＩＣ法分离定量的研究。优选了ＨＰＬＣ条件，确立了以Ｃ（１８）柱及不同比例甲醇－水为流动相系统对５－ＩＳＭＮ、ＩＳＤＮ的定量分析方法。经过方法认证研究表明该法优于国内外报导方法，专属性强，灵敏度高，并对不同批号样品进行了检测。

It was reported in this paper that the physical and chemical constants of isosorbide dinitrate(ISDN) isosorbide-5-mononitrate(5-ISMN) and isosorbide-2-mononitrate(2-ISMN) were determined. that the related materials were isolated qualitatively by TLC, and were also separated and determined quantitatively by HPLC. On the basis of optimization of the HPLC conditions, the quantitative analytical method for determination of 5-ISMN and ISDN was established with C_(18) column as well as mobile phase system by means of the different ratio of methanol to water. The studies showed that the method was better than others reported in the literature, and excellent in specificity and high selectivity. The method was approved by determination of different batches of samples.