Raether G
Ernst-Moritz-Arndt University, Greifswald, BRD.
Acta Pharm Hung. 1991 Sep;61(5):231-8.
The selection of a suitable procedure for stabilizing a drug in various pharmaceutical formulations requires highly specific and accurate analytical methods. In this paper the general problems associated with the specificity of the selected analytical methods (spectrophotometry, HPLC etc.) are discussed through the examples of phenyl-alkylamine and phenothiazine drugs. Studying the influence of different antioxidants on the rate of decomposition and detecting simultaneously the decomposition products, radicals and intact active ingredients enabled a better understanding of the degradation mechanism. The impurity profile (different decomposition products in the mixture) was found to be the function of the type and concentration of the stabilizers. A kinetic study demonstrated on phenylalkylamine type drugs using selective analytical methods clarified the mechanism of stabilizer action and allowed the perfect description of the degradation pathway.
为在各种药物制剂中稳定药物而选择合适的方法需要高度特异且准确的分析方法。本文通过苯烷基胺类和吩噻嗪类药物的例子，讨论了与所选分析方法（分光光度法、高效液相色谱法等）特异性相关的一般问题。研究不同抗氧化剂对分解速率的影响，并同时检测分解产物、自由基和完整的活性成分，有助于更好地理解降解机制。发现杂质谱（混合物中不同的分解产物）是稳定剂类型和浓度的函数。使用选择性分析方法对苯烷基胺类药物进行的动力学研究阐明了稳定剂的作用机制，并能完美描述降解途径。
