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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 determine the related substances contained in hydrocortisone raw materials and their injection. Methods: High-performance liquid chromatography (HPLC) was used for the analysis of the impurities while the diode array detector was used for impurity spectral scanning. The structure of major impurities was confirmed by LC-MS. Results: Hydrocortisone and impurity peaks separated well and the major impurities of the test samples were confirmed to be 6,17,21β-trihydroxypregna-4-ene-3,20-dione, epicortix, 17,21- Dihydroxypregn-4-ene-3,20-dione, cortisone and prednisolone. Conclusion: This method is accurate, sensitive and has good detection of impurities. It is suitable for the determination of related substances of hydrocortisone and its injection.