View More View Less
  • 1 Department of Pharmaceutical Chemistry, Sinhgad Technical Education Society Sinhgad Institute of Pharmacy, Narhe, Pune 411041, Maharashtra, India
Restricted access


The objective of this study was to develop a new rapid and robust high-performance thin-layer chromatographic (HPTLC) method for the estimation of rivaroxaban (RRB) in tablet dosage form using a quality by design approach. Chromatography was performed using a pre-coated silica gel aluminum plate 60 F254 (10 cm × 10 cm) as the stationary phase and toluene–methanol (7:3, V/V) as the mobile phase. Detection was carried out at 250 nm. The linear regression analysis data for the calibration plots showed r2 > 0.99 with a concentration range from 100–600 ng per band. A Box-Behnken experimental design with a response surface methodology was applied to study the effects of chamber saturation time, band length, and solvent front on the RF value and area of RRB. The RF value was predicted to be 0.63 ± 0.05 for RRB to optimize the chromatographic conditions based on the preliminary trials. The optimized HPTLC method was validated according to the International Conference on Harmonization (ICH) guideline Q2 (R1). The results of this study indicate that the quality by design (QbD) concept could be effectively applied to optimize a HPTLC method with a minimum number of experimental runs. The developed HPTLC method was successfully applied for routine analysis of RRB in tablet dosage form.

  • [1]

    K. Chandra , P. Satya, A. Dhana, C. Anupama, N. Devanaboyina, A new method for development and validation for analysis of rivaroxaban in formulation by RP-HPLC, Res. Desk. 1 (2012) 2433.

    • Search Google Scholar
    • Export Citation
  • [2]

    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guidelines, Q1A (R2) (2003): Stability Testing of New Drug Substances and Products, Geneva, 2005, 1–24.

  • [3]

    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use Guidelines, Q2 (R1) (2005): Validation of Analytical Procedures, Geneva, 2005, 1–17.

  • [4]

    I. Lories , A. Mostafa, M. Girges, High performance liquid chromatography, TLC densitometry, first derivative and first derivative ratio spectrophotometry for determination of rivaroxaban and its alkaline degradates in bulk powder and its tablets, J. Chromatogr. Sep. Tech. 4 (2013) 2022010.

    • Search Google Scholar
    • Export Citation
  • [5]

    A. Mohamed , A. Medhat, Al-Ghobashy, M. Hayam, Investigation of the profile and kinetics of degradation of rivaroxaban using HPLC, TLC-densitometry and LC-MS/MS: application to pre-formulation studies, Bull. Fac. Pharm. (Cairo Univ). 53 (2015) 5361.

    • Search Google Scholar
    • Export Citation
  • [6]

    E. Perzborn , S. Roehrig, A. Straub, D. Kubitza, W. Mueck, V. Laux, A new oral factor Xa inhibitor, Arter. Thromb. Vasc. Biol. 30 (2010) 376381.

    • Search Google Scholar
    • Export Citation
  • [7]

    S. Roehrig , A. Straub, J. Pohlmann, T. Lampe, J. Pernerstorfer, K. Schlemmer, P. Reinemer, E. Perzborn, Discovery of the novel antithrombotic agent 5-chloro-N-({(5 S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor, J. Med. Chem. 48 (2005) 59005908.

    • Search Google Scholar
    • Export Citation
  • [8]

    P. Sadanshio , S. Wankhede, P. Chaudhari, Validated stability indicating HPTLC method for estimation of ribavirin in capsule in presence of its alkaline hydrolysis degradation product, Anal. Chem. Lett. 4 (2014) 343358.

    • Search Google Scholar
    • Export Citation
  • [9]

    C. Sekaran , V. Bind, M. Damayanthi, A. Sireesha, Development and validation of UV spectrophotometric method for the determination of rivaroxaban, Der Pharma Chem. 5 (2013) 15.

    • Search Google Scholar
    • Export Citation
  • [10]

    B. Seshamamba , P. Venkata, Application of stability indicating HPLC method with UV detector to the analysis of rivaroxaban in bulk and tablet dosage form, Chem. Sci. Trans. 10 (2014) 893899.

    • Search Google Scholar
    • Export Citation
  • [11]

    A. Thomas , S. Patil, R. Nanda, L. Kothapalli, S. Bhosle, A. Deshpande, Stability-indicating HPTLC method for simultaneous determination of nateglinide and metformin hydrochloride in pharmaceutical dosage form, Saudi Pharm. J. 19 (2011) 221231.

    • Search Google Scholar
    • Export Citation
  • [12]

    D. Vaghela , P. Patel, High performance thin layer chromatographic method with densitometry analysis for determination of rivaroxaban from its tablet dosage form, Int. J. Pharm. Pharm. Sci. 6 (2014) 123128.

    • Search Google Scholar
    • Export Citation

For Submission Guideline click HERE

Manuscript Submission: JPC Manuscript Submission

Senior editors

Editor(s)-in-Chief: B. Spangenberg

Managing Editor: Kakuk Ágnes

Editorial Board

  • T.H. Dzido (Lublin, Poland)
  • Á. M. Móricz (Budapest, Hungary)
  • C.F. Poole (Detroit, MI, USA)
  • E. Reich (Muttenz, Switzerland)
  • B. Renger (Radolfzell, Germany)
  • I. Vovk (Ljubljana, Slovenia)


Advisory Board

  • E. BODOKI (Cluj-Napoca, Romania)
  • U. A. TH. BRINKMAN (Amsterdam, The Netherlands)
  • I. CHOMA (Lublin, Poland)
  • V. COMAN (Cluj-Napoca, Romania)
  • W. DAMMERTZ (Kressbronn, Germany)
  • K. FERENCZI-FODOR (Budapest, Hungary)
  • G. INDRAYANTO (Surabaya, Indonesia)
  • R. E. KAISER (Bad Dürkheim, Germany)
  • I. KLEBOVICH (Budapest, Hungary)
  • T. KOWALSKA (Katowice, Poland)
  • L. LEPRI (Florence, Italy)
  • E. MINCSOVICS (Budapest, Hungary)
  • D. NUROK (Indianapolis, IN, USA)
  • B. RENGER (Radolfzell, Germany)
  • J. K. RÓŻYŁO (Lublin, Poland)
  • J. SHERMA (Easton, PA, USA)
  • M. WAKSMUNDZKA-HAJNOS (Lublin, Poland)
  • D. WEDGE (Mississippi, USA)

A. Kakuk - Managing Editor, Akadémiai Kiadó
Address: P.O. Box 245. H-1519 Budapest, Hungary
Fax: +36 1 464 82 95

Indexing and Abstracting Services:

  • Science Citation Index
  • Sci Search Research Alert
  • Chemistry Citation Index and Current Content/Physical
  • Chemical and Earth Sciences


Journal of Planar Chromatography - Modern TLC
Language English
Size A4
Year of
per Year
per Year
Founder Akadémiai Kiadó
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Chief Executive Officer, Akadémiai Kiadó
ISSN 0933-4173 (Print)
ISSN 1789-0993 (Online)

Monthly Content Usage

Abstract Views Full Text Views PDF Downloads
Jun 2021 10 0 0
Jul 2021 12 0 0
Aug 2021 47 0 0
Sep 2021 20 0 0
Oct 2021 16 0 0
Nov 2021 19 0 0
Dec 2021 3 0 0