Acta Chromatographica
Volume/Issue:
Volume 22: Issue 4
HPTLc method development and validation for analysis of risperidone in formulations, and in-vitro release study
Authors:
R. B. Patel R. College of Pharmacy and G. H. Patel Institute of Pharmacy, Sardar Patel University, Vallabh Vidyanagar, 388 120, India

Search for other papers by R. B. Patel in
Current site
Google Scholar
PubMed Close
,
B. G. Patel R. College of Pharmacy and G. H. Patel Institute of Pharmacy, Sardar Patel University, Vallabh Vidyanagar, 388 120, India

Search for other papers by B. G. Patel in
Current site
Google Scholar
PubMed Close
,
M. R. Patel Indukaka Ipcowala College of Pharmacy, Sardar Patel University, New Vallabh Vidyanagar, 388 121, India

Search for other papers by M. R. Patel in
Current site
Google Scholar
PubMed Close
, and
K. K. Bhatt Indukaka Ipcowala College of Pharmacy, Sardar Patel University, New Vallabh Vidyanagar, 388 121, India

Search for other papers by K. K. Bhatt in
Current site
Google Scholar
PubMed Close
Pages:
549–567
Online Publication Date:
01 Dec 2010
Publication Date:
01 Dec 2010
Article Category:
Research Article
DOI:
https://doi.org/10.1556/achrom.22.2010.4.5
Keywords:
equilibrium solubility; HPTLC; in-vitro diffusion; mucoadhesive microemulsion; risperidone; pH-solubility profile
Open access

Summary

A new, simple, and rapid high-performance thin-layer chromatographic method has been established for quantitative analysis of risperidone. Chromatography was performed on silica gel 60 F254 plates with methanol-ethyl acetate 8.0:2.0 (v/v) as mobile phase. Risperidone was quantified by densitometric analysis at 285 nm. The method gave compact bands for the drug (RF 0.34 ± 0.01). Linear regression analysis of calibration data revealed a good linear relationship (r2 = 0.9996) between response and amount of risperidone in the range 100–600 ng per band. The method was validated for precision, recovery, repeatability, linearity, specificity, and robustness in accordance with ICH guidelines. The minimum detectable amount was 22.44 ng per band and the limit of quantification was 68.01 ng per band. Statistical analysis of the results showed the method enabled precise, accurate, reproducible, and selective analysis of risperidone. The method was successfully used for estimation of the equilibrium solubility of risperidone, and for quantification of risperidone as the bulk drug in a commercially available preparation, in in-house-developed mucoadhesive microemulsion formulations, and in solution.

  • [1]. J. Carman J. Peuskens A. Vangeneugden 1995 Int. Clin. Psychopharmacol. 10 207–213.

  • [2]. H. He J.S. Richardson 1995 Int. Clin. Psychopharmacol. 10 19–30.

  • [3]. A.A. Megens F.H. Awouters A. Schotte T.F. Meert C. Dugovic C.J. Niemegeers J.E. Leysen 1993 Psychopharmacology 114 9–23.

  • [4]. C.R. Behl H.K. Pimplaskar A.P. Sileno J. De Meireles V.D. Romeo 1998 Adv. Drug Del. Rev. 29 89–116.

  • [5]. L.G. Candace G.M. Pollock 2005 J. Pharm. Sci. 94 187–195.

  • [6]. H.S. Chow Z. Chen G.T. Matsuura 1999 J. Pharm. Sci. 88 754–758.

  • [7]. T.K. Vyas A.K. Babber R.K. Sharma S. Singh A. Misra 2006 J. Pharm. Sci. 95 570–580.

  • [8]. L. Li I. Nandi K.H. Kim 2002 Int. J. Pharm. 237 77–85.

  • [9]. S. Mathison R. Nagilla U.B. Kompella 1998 J. Drug Target 56 415–441.

  • [10]. R. Pietrowky A. Thieman W. Kern H.L. Fehm J. Bern 1996 Psychoneuroendocrinology 21 559–572.

  • [11]. Z. Qizhi X. Jiang W. Xiang W. Lu L. Su Z. Shi 2004 Int. J. Pharm. 275 85–96.

  • [12]. M.J. Lawrence G.D. Rees 2000 Adv. Drug Deliv. Rev. 45 89–121.

  • [13]. K.E. Goeringa I.M. McIntyre O.H. Drunmer 2003 J. Anal. Toxicol. 27 30–35.

  • [14]. D. Thieme H. Saches 2003 J. Anal. Chim. Acta 492 171–186.

  • [15]. A. Pelander I. Ojanpera S. Laks I. Rasanen E. Vuori 2003 J. Anal. Chem. 75 5710–5718.

  • [16]. A.E. Balant-Gorgia M. Gex-Fabry C. Genet L.P. Balant 1999 J. Ther. Drug Monit. 21 105–115.

  • [17]. M. Aravagiri S.R. Marder T. Van-Putten K.K. Midha 1993 J. Pharm. Sci. 82 447–449.

  • [18]. A.C. Springfield E. Bodiford 1996 J. Anal. Toxicol. 20 202–203.

  • [19]. G. Casamenti R. Mandrioli C. Sabbioni F. Bugamelli V. Volterra M.A. Raggi 2000 J. Chromatogr. Relat. Technol. 23 1039–1059.

  • [20]. M.A. Raggi G. Casamenti R. Mandrioli C. Sabbioni V. Volterra 2000 J. Pharm. Biomed. Anal. 23 161–167.

  • [21]. M. Andersson U.K. Hultin A. Sokolowski 1998 Chromatographia 48 770–776.

  • [22]. R. Woestenborghs W. Lorreyne F. Van Rompaey J. Heykants 1992 J. Chromatogr. Biomed. Appl. 121 223–230.

  • [23]. J.P. Le-Moing S. Edouard J.C. Levron 1993 J. Chromatogr. Biomed. Appl. 125 333–339.

  • [24]. O.V. Olesen K. Linnet 1997 J. Chromatogr. Biomed. Appl. 698 209–216.

  • [25]. M.C. Price D.W. Hoffman 1997 J. Ther. Drug Monit. 19 333–337.

  • [26]. M. Aravagiri S.R. Marder D. Wirshing W. C. Wirshing 1998 Pharmacopsychiatry 31 102–109.

  • [27]. T. Nagasaki T. Ohkubo K. Sugawara N. Yasui H. Furukori S. Kaneko 1999 J. Pharm. Biomed. Anal. 19 595–601.

  • [28]. H. Xiao J. Yang S.N. Zhang X.B. Zhang 1999 Sepu 17 395–396.

  • [29]. A. Avenoso G. Facciola M. Salemi E. Spina 2000 J. Chromatogr. B Biomed. Sci. Appl. 746 173–181.

  • [30]. D.S. Schatz A. Saria 2000 Pharmacology 60 51–56.

  • [31]. C. Frahnert M.L. Rao K. Grasmaeder 2003 J. Chromatogr. B Anal, Technol. Biomed. Life Sci. 794 35–47.

  • [32]. K. Titier S. Bouchet F. Pehourcq N. Moore M. Molimard 2003 J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 799 179–183.

  • [33]. K. Titier E. Deridet E. Cardone A. Abouelfath N. Moore 2002 J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 772 373–378.

  • [34]. Y.L. Shen H.L. Wu W.K. Ko S.M. Wu 2002 J. Anal. Chim. Acta 460 201–208.

  • [35]. A. Lierena R. Berecz P. Dorado C. Sanz-de-la-Garza M.J. Norberto M. Caceres J.R. Gutierrez 2003 J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 783 213–219.

    • Search Google Scholar
    • Export Citation

  • [36]. B.M.M. Remmerie L.L.A. Sipes R. De-Vries J. De-Jong A.M. Schothuis E.W.J. Hooi Jschuur N.C. Van-de-Merbel 2003 J. Chromatogr. B Anal. Technol., Biomed. Life Sci. 783 461–472.

    • Search Google Scholar
    • Export Citation

  • [37]. M. Aravagiri S.R. Marder 2000 J. Mass Spectrom. 35 718–724.

  • [38]. S. McClean E.J. O'Kane W.F. Smyth 2000 J. Chromatogr B Biomed. Appl. 740 141–157.

  • [39]. M. Gergov I. Ojanpera E. Vuori 2003 J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 795 41–53.

  • [40]. A. Pelander I. Ojanpera J. Sistonen I. Rasanen E. Vuori 2003 J. Anal., Toxicol. 27 226–232.

  • [41]. J. Schuberth 1996 J. Anal. Chem. 68 1317–1320.

  • [42]. H.H. Maurer T. Kraemer C. Kratzsch F.T. Peters A.A. Weber 2002 J. Ther. Drug Monit. 24 117–124.

  • [43]. V. Pucci M.A. Raggi E. Kenndler 2000 J. Liq. Chromatogr. Relat. Technol. 23 25–34.

  • [44]. V. Pucci M.A. Raggi E. Kenndler 2000 J. Chromatogr. B Biomed. Appl. 728 263–271.

  • [45]. X.F. Zhu S. Thiam B.C. Valle I.M. Warner 2002 J. Anal. Chem. 74 5405–5409.

  • [46]. Z.A. El-Sherif B. El-Zeany O.M. El-Houssini 2005 J. Pharm. Biomed. Anal. 36 975–981.

  • [47]. R.B. Patel A.B. Patel M.R. Patel M.B. Shankar K.K. Bhatt 2009 Anal. Lett. 42 1588–1602.

  • [48]. V.B. Borhade H.A. Nair D.D. Hegde C.R. Barhate 2009 Drug Dev. Ind. Pharm. 35 440–448.

  • [49]. R.B. Patel M.R. Patel M.B. Shankar K.K. Bhatt 2008 J. AOAC Int. 91 750–755.

  • [50]. Validation of Analytical Procedure: Methodology Q2 (R1) International Conference on Harmonization (ICH), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland, 1996.

    • 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 14 11
Jul 2024 0 15 9
Aug 2024 0 36 23
Sep 2024 0 30 13
Oct 2024 0 45 20
Nov 2024 0 68 4
Dec 2024 0 29 2