Acta Chromatographica
Volume/Issue:
Volume 26: Issue 2
Development and validation of a rapid and sensitive LC-MS/MS method for the determination of aripiprazole in human plasma: Application to a bioequivalence study
Authors:
D. S. Patel Chemistry Department, Pramukh Swami Science and H.D. Patel Arts College, Sarva Vidyalaya Campus, Kadi, 382 715, Gujarat, India
Bio-Analytical Laboratory, BA Research India Ltd., Bodakdev, Ahmedabad, 380054, Gujarat, India

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N. Sharma Bio-Analytical Laboratory, BA Research India Ltd., Bodakdev, Ahmedabad, 380054, Gujarat, India

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M. C. Patel Chemistry Department, Pramukh Swami Science and H.D. Patel Arts College, Sarva Vidyalaya Campus, Kadi, 382 715, Gujarat, India

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B. N. Patel Bio-Analytical Laboratory, BA Research India Ltd., Bodakdev, Ahmedabad, 380054, Gujarat, India
Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad, 380009, Gujarat, India

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P. S. Shrivastav Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad, 380009, Gujarat, India

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M. Sanyal Department of Chemistry, St. Xavier's College, Navrangpura, Ahmedabad, 380009, Gujarat, India

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Pages:
203–227
Online Publication Date:
01 Jun 2014
Publication Date:
01 Jun 2014
Article Category:
Research Article
DOI:
https://doi.org/10.1556/achrom.26.2014.2.2
Keywords:
aripiprazole; LC-MS/MS; liquid-liquid extraction; human plasma; bioequivalence; incurred sample reanalysis
Open access

Summary

A rapid, selective, and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been proposed for the determination of aripiprazole in human plasma. The analyte and propranolol as internal standard (IS) were extracted from 200 μL of human plasma via liquid-liquid extraction using methyl tert-butyl ether under alkaline conditions. The best chromatographic separation was achieved on an Aquasil C18 (100 × 2.1 mm, 5 μm) column using methanol-deionized water containing 2 mM ammonium trifluoroacetate and 0.02% formic acid (65:35, v/v) as the mobile phase under isocratic conditions. Detection of analyte and IS was done by tandem mass spectrometry, operating in positive ion and multiple reaction monitoring (MRM) acquisition mode. The method was fully validated for its selectivity, interference check, sensitivity, carryover check, linearity, precision and accuracy, reinjection reproducibility, recovery, matrix effect, ion suppression/enhancement, stability, ruggedness, and dilution integrity. The assay was linear over the concentration range of 0.10–100 ng mL−1 for aripiprazole. The intra-batch and inter-batch precision (%CV) was ≤4.8%, while the mean extraction recovery was >96% for aripiprazole across quality control levels. The method was successfully applied to a bioequivalence study of 10 mg aripiprazole orally disintegrating tablet formulation in 27 healthy Indian subjects under fasting and fed condition. The reproducibility in the measurement of study data was demonstrated by reanalysis of 260 incurred samples.

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Cover Acta Chromatographica
Acta Chromatographica
Online ISSN:
2083-5736

Senior editors

Editor(s)-in-Chief: Sajewicz, Mieczyslaw, University of Silesia, Katowice, Poland

Editors(s)

  • Danica Agbaba, University of Belgrade, Belgrade, Serbia (1953-2024)
  • Łukasz Komsta, Medical University of Lublin, Lublin, Poland
  • Ivana Stanimirova-Daszykowska, University of Silesia, Katowice, Poland
  • Monika Waksmundzka-Hajnos, Medical University of Lublin, Lublin, Poland

Editorial Board

  • Ravi Bhushan, The Indian Institute of Technology, Roorkee, India
  • Jacek Bojarski, Jagiellonian University, Kraków, Poland
  • Bezhan Chankvetadze, State University of Tbilisi, Tbilisi, Georgia
  • Michał Daszykowski, University of Silesia, Katowice, Poland
  • Tadeusz H. Dzido, Medical University of Lublin, Lublin, Poland
  • Attila Felinger, University of Pécs, Pécs, Hungary
  • Kazimierz Glowniak, Medical University of Lublin, Lublin, Poland
  • Bronisław Glód, Siedlce University of Natural Sciences and Humanities, Siedlce, Poland
  • Anna Gumieniczek, Medical University of Lublin, Lublin, Poland
  • Urszula Hubicka, Jagiellonian University, Kraków, Poland
  • Krzysztof Kaczmarski, Rzeszow University of Technology, Rzeszów, Poland
  • Huba Kalász, Semmelweis University, Budapest, Hungary
  • Katarina Karljiković Rajić, University of Belgrade, Belgrade, Serbia
  • Imre Klebovich, Semmelweis University, Budapest, Hungary
  • Angelika Koch, Private Pharmacy, Hamburg, Germany
  • Piotr Kus, Univerity of Silesia, Katowice, Poland
  • Debby Mangelings, Free University of Brussels, Brussels, Belgium
  • Emil Mincsovics, Corvinus University of Budapest, Budapest, Hungary
  • Ágnes M. Móricz, Centre for Agricultural Research, Budapest, Hungary
  • Gertrud Morlock, Giessen University, Giessen, Germany
  • Anna Petruczynik, Medical University of Lublin, Lublin, Poland
  • Robert Skibiński, Medical University of Lublin, Lublin, Poland
  • Bernd Spangenberg, Offenburg University of Applied Sciences, Germany
  • Tomasz Tuzimski, Medical University of Lublin, Lublin, Poland
  • Adam Voelkel, Poznań University of Technology, Poznań, Poland
  • Beata Walczak, University of Silesia, Katowice, Poland
  • Wiesław Wasiak, Adam Mickiewicz University, Poznań, Poland
  • Igor G. Zenkevich, St. Petersburg State University, St. Petersburg, Russian Federation

 

SAJEWICZ, MIECZYSLAW
E-mail:mieczyslaw.sajewicz@us.edu.pl

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Acta Chromatographica
Language English
Size A4
Year of
Foundation		 1988
Volumes
per Year		 1
Issues
per Year		 4
Founder Institute of Chemistry, University of Silesia
Founder's
Address		 PL-40-007 Katowice, Poland, Bankowa 12
Publisher Akadémiai Kiadó
Publisher's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Responsible
Publisher		 Chief Executive Officer, Akadémiai Kiadó
ISSN 2083-5736 (Online)

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