Acta Chromatographica
Volume/Issue:
Volume 22: Issue 4
Stability-indicating RP-HPLC method for analysis of telmisartan in the bulk drug and in formulations
Authors:
S. V. Londhe Department of Pharmaceutical Chemistry, Sinhgad College of Pharmacy, Vadgaon, Pune, 411041, India

Search for other papers by S. V. Londhe in
Current site
Google Scholar
PubMed Close
,
N. Kaul Department of Quality Assurance Techniques, Bharati Vidyapeeth Deemed University, Poona College of Pharmacy, Erandwane, Pune, 411038, Maharashtra State, India

Search for other papers by N. Kaul in
Current site
Google Scholar
PubMed Close
,
H. Agrawal Department of Quality Assurance Techniques, Bharati Vidyapeeth Deemed University, Poona College of Pharmacy, Erandwane, Pune, 411038, Maharashtra State, India

Search for other papers by H. Agrawal in
Current site
Google Scholar
PubMed Close
, and
K. R. Mahadik Department of Quality Assurance Techniques, Bharati Vidyapeeth Deemed University, Poona College of Pharmacy, Erandwane, Pune, 411038, Maharashtra State, India

Search for other papers by K. R. Mahadik in
Current site
Google Scholar
PubMed Close
Pages:
539–548
Online Publication Date:
01 Dec 2010
Publication Date:
01 Dec 2010
Article Category:
Research Article
DOI:
https://doi.org/10.1556/achrom.22.2010.4.4
Keywords:
telmisartan; RP-HPLC; validation; stress study
Open access

Summary

A sensitive and reproducible HPLC method has been developed for quantitative analysis of telmisartan. The drug was separated from its degradation products on a C18 column at ambient temperature with methanol-water 80:20 (v/v), pH 4.0 (adjusted by addition of orthophosphoric acid), as mobile phase at a flow rate of 1.0 mL min−1. Under these conditions the retention time of telmisartan was 4.85 ± 0.05 min. Quantification on the basis of peak area was achieved by UV detection at 225 nm; calibration plots were linear in the concentration range 10–60 μg mL−1. When the method was applied to a pharmaceutical formulation there was no chromatographic interference from tablet excipients. The method was validated for precision, robustness, recovery, and limits of detection and quantification. The drug was subjected to acidic and alkaline hydrolysis, and oxidising, dry heat, wet heat, and photodegrading conditions. Because the method could effectively separate the drug from its degradation products, it can be regarded as stability indicating.

  • [1]. J.M. Neutel D.H. Smith 1998 Adv. Ther. 15 206.

  • [2]. S. Hillaert W. Van den Bossche 2003 J. Pharm. Biomed. Anal. 31 329.

  • [3]. S. Hillaert T.R.M. De Beer J.O. De Beer W. Van den Bossche 2003 J. Chromatogr. A 984 135.

  • [4]. M. Xu J. Song Y. Liang 2004 J. Pharm. Biomed. Anal. 34 681.

  • [5]. M.S. Palled P.M.N. Rajesh M. Chatter 2005 AR Bhat, IJPS 67 108.

  • [6]. N. Torrealday L. Gonzalez R.M. Alonso R.M. Jimenz E. Ortiz Lastra 2003 J. Pharm. Biomed. Anal. 32 847.

  • [7]. B. Chen Y. Liang Y. Wang F. Deng P. Zhou F. Guo L. Haung 2005 Anal. Chim. Acta 540 367.

  • [8]. P. Li Y. Wang Y. Wang Y. Tang J. P. Fawcett Y. Cui J. Gu 2005 J. Chromatogr. B 828 126.

  • [9]. C. Hempen L. Gläsle-Schwarz U. Kunz U. Karst 2006 Anal. Chim. Acta 560 35.

  • [10]. C. Hempen L. Gläsle-Schwarz U. Kunz U. Karst 2006 Anal. Chim. Acta 560 41.

  • [11]. ICH, Q1A Stability Testing of New Drug Substances and Products, in: Proceedings of the International Conference on Harmonization, Geneva, October, 1993.

    • Search Google Scholar
    • Export Citation

  • [12]. ICH, Q2A, Harmonised Tripartite Guideline, Text on Validation of Analytical Procedures, IFPMA, in: Proceedings of the International Conference on Harmonization, Geneva, March, 1994.

    • Search Google Scholar
    • Export Citation

  • [13]. ICH, Q2B, Harmonised Tripartite Guideline, Validation of Analytical Procedure: Methodology, IFPMA, in: Proceedings of the International Conference on Harmonization, Geneva, March, 1996.

    • Search Google Scholar
    • Export Citation

  • [14]. ICH Guidance on Analytical Method Validation, in: Proceedings of the International Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September, 2002.

    • Search Google Scholar
    • Export Citation
  • Collapse
  • Expand
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
  • 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

Indexing and Abstracting Services:

  • Science Citation Index
  • Sci Search
  • Research Alert
  • Chemistry Citation Index and Current Content/Physical
  • Chemical and Earth Sciences
  • SCOPUS
  • GoogleScholar
  • Index Copernicus
  • CABI
  • CABELLS Journalytics

2023  
Web of Science  
Journal Impact Factor 1.7
Rank by Impact Factor Q3 (Chemistry, Analytical)
Journal Citation Indicator 0.43
Scopus  
CiteScore 4.0
CiteScore rank Q2 (General Chemistry)
SNIP 0.706
Scimago  
SJR index 0.344
SJR Q rank Q3

Acta Chromatographica
Publication Model Online only
Gold Open Access
Submission Fee none
Article Processing Charge 400 EUR/article
Effective from  1st Feb 2025:
700 EUR/article
Regional discounts on country of the funding agency World Bank Lower-middle-income economies: 50%
World Bank Low-income economies: 100%
Further Discounts Editorial Board / Advisory Board members: 50%
Corresponding authors, affiliated to an EISZ member institution subscribing to the journal package of Akadémiai Kiadó: 100%
Subscription Information Gold Open Access
Purchase per Title  

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)

Monthly Content Usage

Abstract Views Full Text Views PDF Downloads
Jun 2024 0 23 23
Jul 2024 0 39 30
Aug 2024 0 56 32
Sep 2024 0 57 22
Oct 2024 0 129 29
Nov 2024 0 145 37
Dec 2024 0 113 17