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| 氢化可的松及其注射液有关物质检查 | |
| 引用本文： | 谢元超,张雷,巩丽萍,王维剑,李军. 氢化可的松及其注射液有关物质检查[J]. 药物分析杂志, 2012, 0(2): 255-260 |
| 作者姓名： | 谢元超 张雷 巩丽萍 王维剑 李军 |
| 作者单位： | 山东省药品检验所 |
| 基金项目： | 国家科技支撑计划课题“临床使用量大面广的药品杂质检测技术和安全控制指标研究”(2008BAI555B01) |
| 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。 |
| 关 键 词： | 类固醇药物 肾上腺皮质激素药物 氢化可的松 杂质分析 泼尼松龙 二羟基孕甾烯-二酮-醋酸酯 二羟基孕甾烯二酮 表氢化可的松 可的松 三羟基孕甾烯二酮 高效液相色谱法 梯度洗脱 二极管阵列检测器 液质联用法 |
Analysis of related substance of hydrocortisone and hydrocortisone injection |
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| XIE Yuan-chao,ZHANG Lei,GONG Li-ping,WANG Wei-jian,LI Jun. Analysis of related substance of hydrocortisone and hydrocortisone injection[J]. Chinese Journal of Pharmaceutical Analysis, 2012, 0(2): 255-260 | |
| Authors: | XIE Yuan-chao ZHANG Lei GONG Li-ping WANG Wei-jian LI Jun |
| Affiliation: | (Shandong Provincial Institute for Drug Control,Jinan 250101,China) |
| Abstract: | 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. |
| Keywords: | steroid drugs adrenocortical hormone hydrocortisone impurity analysis prednisolone dihydroxypregn-ene-dione acetate dihydroxypregn ene dione epihydrocortisone cortisone trihydroxypregn-en-dione HPLC gradient elution diode array detector LC-MS |
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