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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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HPLC-MS/MS法测定人血浆中赖诺普利片的浓度___

HPLC-MS/MS determination of lisinopril tablets in human plasma

分类号:
出版年·卷·期(页码):2009,29 (6):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

摘要目的:建立高效液相色谱-质谱/质谱联用测定人血浆中赖诺普利浓度的方法,用于赖诺普利口腔崩解片的人体相对生物利用度和生物等效性研究。方法:使用Hypurity Cb67890b柱(2.1 mm×150 mm,5 μm),以0.1%甲酸-乙腈(30∶70)为流动相,流速为0.2 mL·mina12345a,柱温为40 ℃。以二级质谱选择离子反应监测方式(SRM)扫描检测。结果:赖诺普利的线性浓度范围为1.64~210 ng·mLa12345a (r=0.9915),最小检出浓度为0.82 ng·mLa12345a。提取回收率大于50%,平均相对回收率在80%~120%范围内。日内与日间变异均小于15%。结论:本法简便、灵敏,可用于赖诺普利的药物代谢动力学和生物等效性研究。

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

AbstractObjective:To establish a method of HPLC-MS/MS to detect lisinopril tablets in human plasma.Methods:Chromatographic column was Hypurity Cb67890b (2.1 mm×150 mm,5 μm);The mobile phase was 0.1% formic acid-acetonitrile (30∶70);The flow rate was 0.2 mL·mina12345a and temperature of column was 40 ℃.A MS/MS selective reaction monitoring mode was taken to quantitate lisinopril in human plasma.Results:Standard curve was linear in the range of 1.64-210 ng·mLa12345a (r=0.9915).The lower limit of detections of lisinopril was 0.82 ng·mLa12345a.The absolute recovery was more than 50%,and the relative recoveries of lisinopril were in the range of 80%-120%.Relative standard deviations of intraday and interday assays of lisinopril were both less than 15%.Conclusion:The method is convenient and sensitive for detecting the concentration of lisinopril in human plasma,it can be used to study the pharmacokinetics and bioequivalence of lisinopril.

-----参考文献:---------------------------------------------------------------------------------------
1YANG Yi-Wen(杨逸文).Progress of lisinopril in clinical application(赖诺普利的临床应用进展).World Clin Drugs(世界临床药物),2003,24(10):22
2WEI Yu-feng(魏宇峰).HPLC-fluorescence method for the determination of lisinopril in human plasma(高效液相色谱荧光法测定健康人血浆中赖诺普利浓度).Clin Pharm (临床药学),2005,14(7):72
3Kousoulos C,Tsatsou G,Dotsikas Y,et al.Development of a rapid liquid chromatography tandem mass spectrometry method for the determination of lisinopril,applicable for a bioequivalence study,employing a 96-well solid phase extracrion protocol.J Anal Chim Acta,2005,551(1-2):177
4Tamimi JJ,Salem II,Alam SM,et al.Bioequivalence evaluation of two brands of lisinopril tablets(Lisotec and Zestril) in healthy human volunteers.J Biopharm Drug Dispos,2005,26(8):335
5Leis HJ,Fauler G,Raspotnig G,et al.Quantitative determination of the angiotensin-converting enzyme inhibitor lisinopril in human plasma by stable isotope dilution gas chromatography/negative ion chemical ionization mass spectrometry.J Rapid Commun Mass Spectrom,1998,12(21):1591
6HUANG Di(黄荻),DING Li-kun(丁莉坤),DING Li(丁黎),et al. LC-MS determination of lisinopril in human plasma and its application in pharmacokinetics(LC-MS法测定人血浆中赖诺普利及其在药代动力学中的应用).J China Pharm Univ (中国药科大学学报),2006,37(5):428
7QIN Wei-wei(覃韦苇),TIAN Yuan(田媛),ZHANG Zun-jian(张尊建),et al. Bioequivalence assessment of two lisinopril tablets in healthy volunteers(赖诺普利片在健康志愿者体内的生物等效性评价).Chin J New Drugs Clin Rem J(中国新药与临床杂志),2006,25(12):88

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