Sadana G S, Ghogare A B
Department of Chemistry, G.N. Khalsa College, Bombay, India.
J Pharm Sci. 1991 Sep;80(9):895-8. doi: 10.1002/jps.2600800919.
A rapid (5 min), accurate, and precise (SD 0.51%) analytical method involving 1H NMR spectroscopy for determination of nifedipine and its photodecomposition products in pharmaceutical preparations is described. Analysis of commercial samples by 1H NMR and USP NF XVII procedures has indicated a maximum difference of 1.0%. The 1H NMR method is recommended for analysis of nifedipine since it provides sufficiently accurate results, together with a unique spectrum as a confirmatory identification of nifedipine, its photodecomposition products, and other impurities.
本文描述了一种快速（5分钟）、准确且精密（标准偏差0.51%）的分析方法，该方法采用1H核磁共振光谱法测定药物制剂中的硝苯地平及其光分解产物。通过1H核磁共振光谱法和美国药典NF XVII方法对市售样品进行分析，结果表明最大差异为1.0%。由于1H核磁共振光谱法能提供足够准确的结果，以及独特的光谱用于硝苯地平及其光分解产物和其他杂质的确证鉴别，因此推荐该方法用于硝苯地平的分析。
