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

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。

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 6,17,21/3 - 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.