Tettey J N, Skellern G G, Grant M H, Midgley J M
Department of Pharmaceutical Sciences, SIBS, University of Strathclyde, Glasgow, UK.
J Pharm Biomed Anal. 1999 Oct;21(1):1-7. doi: 10.1016/s0731-7085(99)00110-7.
A procedure for the evaluation of chemical equivalence of proprietary formulations of isometamidium is described. The method combines the analysis of the principal component (isometamidium), HPLC profiling of related substances and determination of the inorganic impurity, ammonium chloride, using a modification of the Berthelot (Indophenol) reaction. Application of these procedures to analyses of commercially available sachets from four different batches of Samorin and four different batches of Veridium has demonstrated that there are marked qualitative and quantitative differences between batches from these two sources. Whilst Samorin samples showed inter-batch consistency of composition, there was considerable inter-batch variation between the samples of Veridium.
描述了一种评估异美替尼专有制剂化学等效性的方法。该方法结合了主成分（异美替尼）分析、相关物质的高效液相色谱图谱分析以及使用改良的贝托洛（靛酚）反应测定无机杂质氯化铵。将这些程序应用于分析来自四个不同批次的Samorin和四个不同批次的Veridium的市售药包，结果表明这两个来源的批次之间存在明显的定性和定量差异。虽然Samorin样品显示出批次间组成的一致性，但Veridium样品之间存在相当大的批次间差异。
