[ Pharmaceutical Sciences Asia - ONLINE ]
Print ISSN 2586-8195 E-ISSN 2586-8470
[ Journal Abbreviation: Pharm.Sci.Asia ]
Mahidol University Journal of Pharmaceutical Sciences
  FORMER NAME   "Mahidol University Journal of Pharmaceutical Sciences" Published Since 1974

 
Abstracts

DOI: https://doi.org/10.29090/psa.2017.04.217Pharm Sci Asia 2017; 44(4), 217-226
 

Development and Validation of Liquid Chromatography Tandem Mass Spectrometry Method for Determination of Amlodipine in Human Plasma and its Application

P. Pongnarin, W. Thanakosai, P. Kingkhangphloo, W. Chandranipapongse, S. Kongpatanakul, S. Chatsiricharoenkul*

- Department of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand


Asensitive liquid chromatography tandem mass spectrometry method was developed to quantify amlodipinein human plasma. Alkalinized plasma spiked with desipramine, an internal standard, was extracted by liquid-liquid extraction andevaporated an organic part to dryness. The residue was reconstituted and injected into anAcquityUltra Performance LCTM, (Waters, Co., Ltd.USA) with C18 column. The isocratic elution of mobile phasewas performed by 90% of acetonitrile and 10% of 10 mM ammonium acetate pH 4 atflow rate of 0.20 mL/min with 5 minutes of total run time. Mass spectrometric analysis was performed using a Quattro Premier XE mass spectrometer, (Micromass Technologies, UK) coupled with an electrospray ionization (ESI) source in the positive ion mode. The MRM transitions of m/z 409.17>238.19 and 409.17>294.09were selected for amlodipineand 267.09>208.06for desipramine. The retention times were 1.63 and 1.69 minutes for amlodipineand desipramine, respectively. The linearity of the method revealed a correlation coefficient of >0.998 within the concentration range of 0.05 - 20 ng/mL. This work has been fully validated according to the Guidance for Industry: Bioanalytical Method Validation (USFDA CDER, 2001, BP) with high degree of accuracy and precision. This assay method was applied to quantify amlodipine concentrations in human plasma samples in a bioequivalence study.




Keyword:

amlodipine, LC-MS/MS, Method development, Method Validation




Download full paper (PDF File size: 1,776.95 KB.)





Vol.44
No.4
October - December 2017

See other volume

 


Vol.44
No.3
July - September 2017

See other volume

 


Vol.44
No.2
April - June 2017

See other volume

 


Vol.44
No.1
January - March 2017

See other volume

 
 
 

Home
Aims and Scope
Editorial Board
Publication Ethics
Instruction to Authors
Announcement
All Volumes & Issues
Submit Online
Contact us
   
Search
   
Faculty of Pharmacy Mahidol University
Mahidol University
Member's menu

You're now loging on with following account:
Guest (unknown)

Please Sign in or Register



    Copyright © 2017
    Faculty of Pharmacy, Mahidol University, THAILAND