酮康唑相关杂质国家标准物质的研制

发布时间：2018-06-15 12:41

本文选题：广谱抗真菌药 + 酮康唑　；参考：《药物分析杂志》2015年03期

【摘要】：目的:研制酮康唑相关杂质标准物质,提升国内酮康唑品种的质控标准。方法:对酮康唑杂质B、C、D、E进行合成与结构确证,并采用中国药典2010年版二部酮康唑有关物质检查方法测定各杂质的纯度,再根据各杂质的水分和炽灼残渣结果用质量平衡法确定首批各杂质国家标准物质的含量。最后采用标准曲线法测定了酮康唑诸杂质对酮康唑在220 nm检测波长下的相对校正因子。结果:研制的酮康唑杂质B、C、D、E标准物质与欧洲药典(EP 8.0版)中规定的结构一致。中国药典2010年版二部中酮康唑有关物质检查项下规定的色谱系统对酮康唑及其各杂质均能有效分离。以质量平衡法表示,本研究标定的酮康唑各杂质B、C、D、E的含量分别为95.2%、97.9%、98.5%和99.4%。各杂质对酮康唑的相对校正因子分别为1.13、1.08、0.94、1.01。结论:建立了首批酮康唑杂质B、C、D、E国家标准物质。
[Abstract]:Objective: to develop ketoconazole related impurity standard material and improve the quality control standard of ketoconazole varieties in China. Methods: the impurity of ketoconazole was synthesized and its structure was confirmed. The purity of each impurity was determined by the Chinese Pharmacopoeia 2010 edition of two ketoconazole related substances. According to the moisture content of each impurity and the result of incandescent residue, the mass balance method was used to determine the content of the first batch of national standard materials of impurity. Finally, the relative correction factors of ketoconazole impurity p-ketoconazole at 220 nm detection wavelength were determined by standard curve method. Results: the structure of ketoconazole impurity BCU DNE was the same as that of EP 8.0 in the European Pharmacopoeia. Ketoconazole and its impurities can be effectively separated by the chromatographic system under ketoconazole related substances in the Chinese Pharmacopoeia 2010 edition. By mass balance method, the contents of each impurity of ketoconazole in this study are 95.2C97.9% and 99.4%, respectively. The relative correction factors of each impurity p-ketoconazole were 1.13 ~ 1.080.94 ~ 1.01 respectively. Conclusion: the first batch of ketoconazole impurity BCU DNE has been established.
【作者单位】：中国食品药品检定研究院;蚌埠市食品药品检验所;
【分类号】：R927

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