Acta Chromatographica
Volume/Issue:
Volume 23: Issue 3
Development and validation of stability-indicating high-performance thin-layer chromatography method for estimation of ciprofibrate in bulk and in pharmaceutical formulation
Authors:
P. S. Jain R. C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur Dist., Dhule, 425 405, M.S., India

Search for other papers by P. S. Jain in
Current site
Google Scholar
PubMed Close
,
H. N. Jivani R. C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur Dist., Dhule, 425 405, M.S., India

Search for other papers by H. N. Jivani in
Current site
Google Scholar
PubMed Close
,
R. N. Khatal R. C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur Dist., Dhule, 425 405, M.S., India

Search for other papers by R. N. Khatal in
Current site
Google Scholar
PubMed Close
, and
S. J. Surana R. C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur Dist., Dhule, 425 405, M.S., India

Search for other papers by S. J. Surana in
Current site
Google Scholar
PubMed Close
Pages:
469–482
Online Publication Date:
01 Sep 2011
Publication Date:
01 Sep 2011
Article Category:
Research Article
DOI:
https://doi.org/10.1556/achrom.23.2011.3.8
Keywords:
ciprofibrate; high-performance thin-layer chromatography (HPTLC); validation; stability; degradation
Open access

Summary

A simple, selective, precise, and stability-indicating high-performance thinlayer chromatography (HPTLC) method for the analysis of ciprofibrate both in bulk drug and pharmaceutical formulation has been developed and validated. The method employed HPTLC aluminum plates precoated with silica gel 60 RP-18 F254 as the stationary phase. The solvent system consisted of methanol-water-triethylamine (2.8:2.2:0.2 υ/υ). The system was found to give compact spot for ciprofibrate (RF value of 0.55 ± 0.02). Densitometric analysis of ciprofibrate was carried out in the absorbance mode at 232 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.998 ± 0.0015 with respect to peak area in the concentration range 600–1600 ng per spot. The mean values ± SD of slope and intercept were 3.38 ± 1.47 and 986.9 ± 108.78, respectively, with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantification were 17.84 and 54.08 ng per spot, respectively. Ciprofibrate was subjected to acid and alkali hydrolysis, oxidation, and thermal degradation. The drug undergoes degradation under acidic and basic conditions. This indicates that the drug is susceptible to acid and base. The degraded product was well resolved from the pure drug with significantly different RF value. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for the identification and quantitative determination of ciprofibrate in bulk drug and pharmaceutical formulation.

  • [1]. Martindale : The Complete Drug Reference, 35th edn, Council of Royal Pharmaceutical Society of Great Britain, 2007, pp. 1118–1119.

    • Search Google Scholar
    • Export Citation

  • [2]. S. Budavari 1996 The Merck Index 14th edn Merck and Co., White House Station New Jersey 386.

  • [3]. Goodman and Gilman's: The Pharmacological Basis of Therapeutics, 10th edn, McGraw-Hill, New York, 2003–2004, pp. 971–1002.

  • [4]. British Pharmacopoeia , Medicinal and Pharmaceutical Substances (A-I), The Stationery Office, London, 2005, Vol. 1, pp. 106–108.

    • Search Google Scholar
    • Export Citation

  • [5]. E.G.B. Bighetti P.R. Patricio A.C. Casquero J.A. Berti H.C.F. Oliveira 2009 Lipids Health Dis. 50 8 1–9.

  • [6]. G. Misztal L. Komsta 2005 J. Planar Chromatogr. 18 3 188–193.

  • [7]. L.D. Masnatta L. A. Cuniberti R.H. Rey J. Werba 1996 J. Chromatogr. B 687 2 437–442.

  • [8]. N.H. Anderson D. Johnston P.R. Vojvodic 1992 J. Pharm. Biomed. Anal. 10 7 501–505.

  • [9]. H. Huttemann G. Blaschke 1999 J. Chromatogr. B 729 1–2 33–41.

  • [10]. P.D. Sethi 1996 High Performance Thin Layer Chromatography: Quantitative Analysis of Pharmaceutical Formulations CBS New Delhi 162–165.

    • Search Google Scholar
    • Export Citation

  • [11]. M. Bakshi S. Singh 2002 J. Pharm. Biomed. Anal. 28 1011–1040.

  • [12]. ICH, Q2A text on validation of analytical procedures, International Conference on Harmonization, Geneva, October 1994.

  • [13]. ICH, Q3B validation of analytical procedures: methodology, International Conference on Harmonization, Geneva, November 1996.

  • 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 (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

Indexing and Abstracting Services:

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

2024  
Scopus  
CiteScore  
CiteScore rank  
SNIP  
Scimago  
SJR index 0.285
SJR Q rank Q3

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

700 EUR/article

For MS submitted before 1 Feb 2025: 400 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
Dec 2024 0 144 1
Jan 2025 0 54 4
Feb 2025 0 77 2
Mar 2025 0 93 17
Apr 2025 0 21 3
May 2025 0 7 2
Jun 2025 0 20 0