氢化可的松及其注射液有关物质检查
Analysis of related substance of hydrocortisone and hydrocortisone injection
分类号：
出版年·卷·期（页码）：2012,32 (2):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的: 对氢化可的松原料及其注射液中含有的有关物质进行测定。 方法: 采用高效液相色谱法进行分析,同时采用二极管阵列检测器进行杂质波谱扫描,液质联用法辅助确定主要杂质的结构。 结果: 氢化可的松和杂质峰分离良好,试验样品主要杂质确证为6,17,21β-三羟基孕甾-4-烯-3,20-二酮、表氢化可的松、17,21-二羟基孕甾-4-烯-3,20-二酮、可的松及泼尼松龙。 结论: 本法准确、灵敏,杂质检出性强,适用于氢化可的松及其注射液有关物质的测定。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To analyze the related substance of hydrocortisone and hydrocortisone injection. Methods: The HPLC method was applied for the analysis of hydrocortisone and its impurities,the diode array detector was adopted to detect the purity of the chromatographic peak,liquid chromatography(LC) coupled with electrospray-mass spectrometry(ESI-MS) was used to identify the related substances. Results: The resolution of hydrocortisone and impurities was good.The major impurities were 6,17,21 β-trihydroxypregn-4-en-3,20-dione,epihydrocortisone,17,21-dihydroxypregn-4-ene-3,20-dione,cortisone and prednisonlone. Conclusion: The method is accurate,sensitive and can be used for determination of the impurities of hydrocortisone and hydrocortisone injection.
-----参考文献：---------------------------------------------------------------------------------------
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