Azcona T, Martin-Gonzalez A, Zamorano P, Pascual C, Grau C, Garcia de Mirasierra M
National Centre of Pharmacobiology (National Institute of Health Carlos III), Madrid, Spain.
J Pharm Biomed Anal. 1991;9(9):725-9. doi: 10.1016/0731-7085(91)80213-s.
Differential scanning calorimetry (DSC) is a method which has been applied to obtain thermal information about both raw material and the determination of the content of 5-ISMN in dry mixtures with lactose. The main advantage this offers, compared to other methods, is that it is not necessary to use a standard, it only being necessary to know the data of its fusion heat. HPLC and TLC-densitometry are considered for the determination of 5-ISMN: lactose and pharmaceutical dosage forms. Linearity test, repeatability and accuracy were satisfactory in both methods. Recovery data in pharmaceutical formulations (expressed as the percentage of the label claim) from HPLC and TLC did not give any significant difference (P = 95%). The results show that the chromatographic methods are simple, fast and reliable procedures for the determination of 5-ISMN.
差示扫描量热法（DSC）是一种已被应用于获取有关原材料的热信息以及测定与乳糖的干燥混合物中5-单硝酸异山梨酯（5-ISMN）含量的方法。与其他方法相比，该方法的主要优点是无需使用标准品，仅需知道其熔化热数据即可。高效液相色谱法（HPLC）和薄层色谱-光密度法用于测定5-ISMN、乳糖及药物剂型。两种方法的线性测试、重复性和准确性均令人满意。HPLC法和薄层色谱法测定药物制剂中的回收率数据（以标示量的百分比表示）没有显著差异（P = 95%）。结果表明，色谱法是测定5-ISMN的简单、快速且可靠的方法。
