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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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HPLC法测定比阿培南二聚物方法研究及其降解途径考察

HPLC determination of biapenem dimer and study on its degradation pathways

分类号:
出版年·卷·期(页码):2012,32 (3):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 建立了测定比阿培南二聚物的高效液相色谱法,同时考察二聚物的降解途径。 方法: 采用高效液相色谱法:色谱柱为C18柱,流动相为0.05%三氟乙酸溶液-乙腈(92:8),检测波长为318 nm,流速为1.0 mL·min-1结果: 比阿培南溶液浓度在0.000 2~0.076 8 mg·mL-1范围内,溶液浓度与峰面积线性关系良好(r=1.000)。比阿培南二聚物A和二聚物B测定结果的重复性良好,RSD(n=6)分别为2.5%和0.8%。 结论: 本方法操作简便,结果可靠,可以用于比阿培南中二聚物的检测。

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

Objective: To establish an HPLC analytical method for the determination of biapenem dimer,and study its degradation pathways. Methods: The analytical Column was C18,the mobile phase was 0.05% trifluloracetic acid solution-acetonitrile(92:8),the detective wavelength was 318 nm,and the flow rate was 1.0 mL·min-1. Results: The biapenem had a good linearity in the range of 0.0002-0.0768 mg·mL-1(r=1.000).Repeatability of biapenem dimer A and dimer B was fine,with RSD(n=6)of 2.5% and 0.8%. Conclusion: The method is simple,rapid and reliable,it is applicable for the quality control of biapenem dimer.

-----参考文献:---------------------------------------------------------------------------------------
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[2] de Wack AL.Drug allergy,immrnotherapy,immune complexes and anaphylexis.Curr opin Immunol,1990,2:548
[3] JIN Shao-hong(金少鸿),HU Chang-qin(胡昌勤).Advanced in the study on allergic reactions of β-lactam antibiotics(β-内酰胺抗生素过敏反应研究进展).Chin New Drugs J(中国新药杂志),1994,3(4):38
[4] QIAO Hai-ling(乔海灵),ZHAO Yong-xing(赵永星),MA Tong-xun(马统勋).The development on allergic reactions and diagnosis of β-lactam antibiotics(青霉素类抗生素过敏反应机制及诊断的新近研究进展).World notes Antibiot (国外医药抗生素分册),2002,23(5):197
[5] Ahlstedt S,Kristofferson A,Svard PO,et al.Ampicillin polymers as elicitiors of passive cutaneous anaphylaxis.Int Arch Allergy Appl Immunol,1976,51(1):131
[6] XIA Ming(夏明),ZHANG Pei(张裴),LI Xiao-min(李小敏),et al.Biapenem dimer and its Preparation Methods(比阿培南二聚物及其制备方法).State intellectual property office of P.R China(中华人民共和国国家知识产权局).Publication Number(公开号):CN101293892A,2008-10-29
[7] XIA Ming,HANG Tai-jun,ZHANG Pei, et al.The stability of biapenem and structural identification of impurities in aqueous solution.J Pharm Biomed Anal,2009,49(4):937

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