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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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液相色谱-质谱联用技术鉴定奥美沙坦酯有关物质

Identification of related substances in olmesartan medoxomil by LC-MS/MS

分类号:
出版年·卷·期(页码):2012,32 (1):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 采用液相色谱-质谱联用技术对奥美沙坦酯中有关物质进行结构鉴定。 方法: 采用LiChrospher C8(250 mm×4.6 mm,5 μm)色谱柱,以甲醇-醋酸铵缓冲液为流动相梯度洗脱,对奥美沙坦酯有关物质进行分离;采用LC-MS/MS电喷雾正离子化测定各有关物质的相对分子质量和二级质谱,并进行结构解析。 结果: 检测到奥美沙坦酯粗品中11个有关物质,并推测出它们的化学结构均为奥美沙坦母核结构未发生变化的不同取代咪唑和四氮唑联苯衍生物。 结论: 色谱-质谱联用技术能够有效地用于药物中有关物质的鉴定,奥美沙坦酯有关物质研究可为其质量控制和工艺优化提供参考依据。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To use hyphenated techniques for the identification of related substances in olmesartan medoxomil. Methods: An LC-MS/MS method was established by using a LiChrospher C8(250 mm×4.6 mm,5 μm)column with gradient elution by a mobile phase consisting of methanol and ammonium acetate buffer solution.Electrospray ionization(ESI)source was operated in positive ion mode.The parent ions and the product ions of the related substances were acquired and elucidated. Results: Eleven related substances were found in olmesartan medoxomil raw material and their structures were elucidated as the different substituents having the same frame structure as olmesartan medoxomil. Conclusion: The hyphenated LC-MS method is useful for the investigation of related substances in pharmaceuticals.The related substances found in olmesartan medoxomil are valuable for its manufacturing process and quality control.

-----参考文献:---------------------------------------------------------------------------------------
[1] TAO Ao(陶傲),LIU Gao-lin(刘皋林).Olmesartan:a novel angiotensin Ⅱ receptor antagonist(奥美沙坦:一种新的血管紧张素Ⅱ 受体拮抗剂).Chin J New Drugs Clin Rem(中国新药与临床杂志),2003,22(6):365
[2] WU Tai-zhi(吴泰志),LIU Xiao-hua(刘晓华),ZHANG Fu-li(张福利),et al.A novel synthesis of olmesartan medoxomil and examination of its related impurities(抗高血压药奥美沙坦酯合成新路线和相关杂质的研究).Acta Pharm Sin(药学学报),2006,41(6):537
[3] Murakami T,Konnoa H,Fukutsua N,et al.Identification of a degradation product in stressed tablets of olmesartan medoxomil by the complementary use of HPLC hyphenated techniques.J Pharm Biomed Anal,2008,47(3):553
[4] PAN Hong-juan(潘红娟),WU Tai-zhi(吴泰志),ZHANG Fu-li(张福利),et al.HPLC determination of olmesartan medoxomil and its related substances(奥美沙坦酯及其相关物质的分离与测定).Chin J Pharm Anal(药物分析杂志),2008,28(11):1883

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