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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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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:---------------------------------------------------------------------------------------
[1] LU Wen-yu(卢文玉),GUO Ya-wen(郭亚文),WANG Min(王敏),et al.Determination of hydrocortisone and related compounds in the culture of hydrocortisone by high performance liquid chromatography(高效液相色谱法测定氢化可的松发酵液中的氢化可的松及其有关物质).Chin J Chromatogr(色谱),2003,21(4):388
[2] ZHANG Bing-hua(张秉华),CHEN Fang(陈芳),SHAO Ying-hua(邵莹华),et al.HPLC-ELSD analysis of hydrocortisone and related substance(HPLC-ELSD法测定氢化可的松有关物质).Chin J Pharm Anal(药物分析杂志),2008,28(11):1912
[3] ZUO Zhi-hui(左志辉),TANG Su-fang(唐素芳).RP-HPLC determination of hydrocortisone acetate eye ointment and its related substances of hydrocortisone acetate injection(反相高效液相色谱法测定醋酸氢化可的松注射液的有关物质及眼膏剂的含量).Chin J Pharm J Anal(药物分析杂志),2010,30(8):1516
[4] ChP(中国药典).2010.VolⅡ(二部):550
[5] USP 32-NF 27.Vol Ⅱ:2573
[6] JP XV:728
[7] BP 2009.Vol Ⅰ:1014
[8] EP6.0.VolⅡ:335
[9] Sreenivasa Rao Chitturi.Impurity profile study of lopinavir and validation of HPLC method for the determination of related substances in lopinavir drug substance.J Pharm Biomed Anal ,2008,48:1430
[10] ChP(中国药典).2010 Vol Ⅱ(二部):Appendix(附录)31
[11] EMA. Guideline setting specifications for related impurities in antibiotics (protocol).2010,7,14

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