Acta Chromatographica
Volume/Issue:
Volume 22: Issue 2
The ICH guidance in practice: Stress degradation studies on irbesartan and development of a validated stability-indicating UPLC assay
Authors:
K. Sahu School of Pharmaceutical Sciences, Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal, 462036, India

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P. Patel School of Pharmaceutical Sciences, Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal, 462036, India

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C. Karthikeyan School of Pharmaceutical Sciences, Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal, 462036, India

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P. Trivedi School of Pharmaceutical Sciences, Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal, 462036, India

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Pages:
189–205
Online Publication Date:
01 Jun 2010
Publication Date:
01 Jun 2010
Article Category:
Research Article
DOI:
https://doi.org/10.1556/achrom.22.2010.2.3
Keywords:
irbesartan stress testing; stability-indicating assay; reverse-phase ultra performance liquid chromatography (RP-UPLC)
Open access

Summary

In this research work comprehensive stress testing of irbesartan was carried out according to ICH guideline Q1A (R2), and a stability-indicating reversed-phase ultra-performance liquid chromatographic (UPLC) assay was established. The drug was subjected to acid (0.1 m HCl), neutral, and alkaline (0.1 m NaOH) hydrolytic conditions at 80°C, and to oxidative decomposition at room temperature. Photolysis was carried out by exposing the drug to sunlight (60,000–70,000 lux) for two days. The solid drug was also subjected to 50°C for 60 days in a hot-air oven. Degradation of the drug was found to occur under alkaline, acidic, and neutral hydrolytic conditions. Separation of the drug and the degradation products was successfully achieved on a BEH (bridged ethylene hybrid) C18 column with 40:60 aqueous glacial acetic acid (0.2%)-acetonitrile as mobile phase. The flow rate and detection wavelength were 0.1 mL min−1 and 229 nm, respectively. The method was validated and response was found to be linear in the drug concentration range 10–50 μg mL−1. The mean values (±RSD, %) of slope, intercept, and correlation coefficient were 32102 (± 0.0535), 1295 (± 3.02), and 0.9998 (± 0.0493), respectively. RSD in intra-day and inter-day precision studies was <1%. Recovery of the drug from a mixture of degradation products was between 99.26 and 100.01%. The method was specific to the drug, selective to degradation products, and robust. PDA purity test also confirmed the specificity of the method.

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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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Journal Impact Factor 1.7
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Acta Chromatographica
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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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