PHYSICOCHEMICAL PROPERTIES, ANALYTICAL DETERMINATIONS AND STABILITY OF SERTACONAZOLE NITRATE

被引:0
|
作者
ALBET, C [1 ]
FERNANDEZ, JM [1 ]
SACRISTAN, A [1 ]
ORTIZ, JA [1 ]
机构
[1] FERRER INT SA,JOAN SADA 32,E-08028 BARCELONA,SPAIN
来源
ARZNEIMITTEL-FORSCHUNG/DRUG RESEARCH | 1992年 / 42-1卷 / 5A期
关键词
ANTIMYCOTICS; CAS-99592-32-2; FI-7045; SERTACONAZOLE NITRATE; ANALYSIS; PHYSICOCHEMICAL CHARACTERISTICS; STABILITY;
D O I
暂无
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Sertaconazole nitrate, the nitrate salt of 7-chloro-3-[1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl) ethoxy-methyl] benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32-2), is a new azole antifungal, which has proved to have a wide spectrum and high activity. This paper describes its physico-chemical properties, structural identification including polymorphism, detection of impurities, determination of related compounds, separation, quantification and purity assays using high-performance liquid chromatography (HPLC) and quantitative assays specially elemental and functional analysis. Stability of sertaconazole nitrate in solid form under accelerated (light, humidity and temperature) and real time conditions and in suspension form at different pH values (acid and basic) was also studied. The results show that sertaconazole nitrate is extremely stable under all the conditions tested, both in solid and in suspension form. Sertaconazole nitrate in solid form packaged in tight sealed amber glass bottles was stable for over 5 years under normal storage conditions.
引用
收藏
页码:695 / 698
页数:4
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