Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Journal of Complementary and Integrative Medicine

Editor-in-Chief: Lui, Edmund

Ed. by Ko, Robert / Leung, Kelvin Sze-Yin / Saunders, Paul / Suntres, PH. D., Zacharias

CiteScore 2017: 1.41

SCImago Journal Rank (SJR) 2017: 0.472
Source Normalized Impact per Paper (SNIP) 2017: 0.564

See all formats and pricing
More options …

Assessment of compliance level of ICH guidelines for organic volatile impurities in common ayurvedic hepatic formulations

M. MaithaniORCID iD: https://orcid.org/0000-0002-9451-439X / R. Raturi
  • Multidisciplinary Research Unit, University Centre of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, India
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ V. Gupta
  • Multidisciplinary Research Unit, University Centre of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, India
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ P. BansalORCID iD: https://orcid.org/0000-0001-9601-6354
Published Online: 2019-03-13 | DOI: https://doi.org/10.1515/jcim-2018-0159



Herbal medicines have been used in the treatment of liver diseases for a long time. In recent years, the use of herbal medicines for protection from other strong antibiotics as well as drugs that can damage the liver during their metabolism in liver and for treatment of liver diseases has increased all over the world. It is important to mention that a number of organic solvents are used at different stages of extraction/formulation development for these traditional preparations in industries/pharmacies. In addition, some of these solvents possess established carcinogenic properties and may enter the formulation as residual solvents. Hence as per ICH guidelines it is mandatory to keep the level of these solvents up to permissible limits. There has been a lot of hue and cry that ayurvedic formulations available in the market are not properly standardized for their quality due to lack of stringent regulations and standards from regulatory authorities. Therefore the aim of present work was to assess the compliance of ICH guidelines for level of organic volatile impurities in common marketed ayurvedic hepatic formulations.


In this study, 25 ayurvedic herbal formulations available as OTC product have been assessed for presence of residual solvents using gas chromatography with flame ionization detector.


This study on 25 fast moving hepatic formulations in the market reflects that no residual solvents were detected in any of the formulations however if present were within prescribed permissible limits of ICH guidelines. The data was also subjected to statistical analysis (F-test and t-test at 95% confidence level).


Results indicate the safety of these hepatic formulations with respect to residual solvents. In addition presents a simple, linear, specific, accurate, precise and rugged gas chromatographic method for estimation of residual solvents.

Keywords: ayurvedic hepatic formulations; ICH guidelines; organic volatile impurities


  • [1]

    Ming H, Sha L, Hor YT, Ning W, Sai WT, Yibin F. Current status of herbal medicines in chronic liver disease therapy: the biological effects, molecular targets and future Prospects. Int J Mol Sci 2015;16:28705–45.CrossrefPubMedWeb of ScienceGoogle Scholar

  • [2]

    Dhiman A, Nanda A, Ahmad S. A recent update in research on the antihepatotoxic potential of medicinal plants. J Chin Integr Med 2012;10:117–27.CrossrefGoogle Scholar

  • [3]

    Del PA, Scalera A, Iadevaia MD, Miranda A, Zulli C, Gaeta L, et al. Herbal products: benefits, limits, and applications in chronic liver disease. Evid Based Complement Altern Med 2012;2012:837939.Web of ScienceGoogle Scholar

  • [4]

    Uorakkottil I, Deepshikha PK, Vidhu A, Punnooth PN. A review on hepatoprotective and immunomodulatory herbal plants. Pharmacogn Rev 2016;10:66–70.CrossrefPubMedGoogle Scholar

  • [5]

    Girish C, Bidhan CK, Jayanthib S, Ramachandra KR, Rajesh B, Suresh CP. Hepatoprotective activity of six polyherbal formulations in CCl4-induced liver toxicity in mice. Indian J Exp Biol 2009;47:257–63.PubMedGoogle Scholar

  • [6]

    El-Shenawy SM, Hassan NS. Comparative evaluation of the protective effect of selenium and garlic against liver and kidney damage induced by mercury chloride in the rats. Pharmacol Rep 2008;60:199–208.PubMedGoogle Scholar

  • [7]

    Subramoniam A, Pushpangadan P. Development of phytomedicines for liver diseases. Indian J Pharmacol 1999;31:166–75.Google Scholar

  • [8]

    Vong S, Bell BP. Chronic liver disease mortality in the United States, 1990–1998. Hepatology 2004;39:476–83.CrossrefPubMedGoogle Scholar

  • [9]

    Kupeli E, Orhan DD, Yesilada E. Effect of Cistus laurifolius L. leaf extracts and flavonoids on acetaminophen-induced hepatotoxicity in mice. J Ethnopharmacol. 2006;103:455–60.CrossrefPubMedGoogle Scholar

  • [10]

    Evans WC. An overview of drugs having antihepatotoxic and oral hypoglycaemic activities. In: Trease and Evans’ WC, eds. Phamacognosy, 14th ed. UK: W.D. Sanders Company Ltd, 1996.Google Scholar

  • [11]

    Gupta V, Bansal P, Bansal R, Kumar S. Value addition by standardization of herbal drugs at global level – a review. Arch Pharm Sci Res 2010;2:326–30.Google Scholar

  • [12]

    Zhang A, Sun H, Wang X. Recent advances in natural products from plants for treatment of liver diseases. Eur J Med Chem 2013;63:570–7.PubMedWeb of ScienceCrossrefGoogle Scholar

  • [13]

    Anupama RV, Neelam M, Rajani BA, Narendra SB. Hepatoprotective ayurvedic plants – a review. J Complement Integr Med 2016;13:207–15.PubMedGoogle Scholar

  • [14]

    Ayurvedic Formulary of India, Part I & II. Department of AYUSH, Ministry of Health & Family Welfare, New Delhi, Government of India; 2005.Google Scholar

  • [15]

    Gupta V, Bansal P, Kumar S, Bansal R, Meena AK, Sharma S. Chromatographic techniques in standardization of herbal drugs – a review. J Punjab Acad Sci 2010;5–6:24–30.Google Scholar

  • [16]

    Meena AK, Bansal P, Kumar S. Herbal wealth as a potential source of ayurvedic drugs. Asian J Tradit Med 2009;4:152–70.Google Scholar

  • [17]

    Ghosh A, Kundu A, Seth A, Singh AK, Maurya SK. Preliminary evaluation of hepatoprotective potential of the polyherbal formulation. J Intercult Ethnopharmacol 2015;4:118–24.PubMedWeb of ScienceCrossrefGoogle Scholar

  • [18]

    Dhiman RK, Chawla YK. Herbal medicines for liver diseases. Dig Dis Sci 2005;50:1807–12.PubMedCrossrefGoogle Scholar

  • [19]

    Seth SD, Sharma B. Medicinal plants of India. Ind J Med Res 2004;120:9–11.Google Scholar

  • [20]

    Chattopadhyay R. Possible mechanism of hepatoprotective activity of Azadirachta indica leaf extract: part II. J Ethnopharmacol. 2003;89:217–9 .CrossrefPubMedGoogle Scholar

  • [21]

    Handa SS, Sharma A, Chakraborty KK. Natural products and plants as liver protecting drugs. Fitoterapia 1989;57:307–51.Google Scholar

  • [22]

    Hikino H, Kiso Y. Natural products for liver diseases. In: H. Wagner, Hiroshi Hikino, Norman Farnsworth, eds. Economic and medicinal plant research, vol. 2. London: Academic Press, 1988:39-72.Google Scholar

  • [23]

    Doreswamy R, Sharma D. Plant drugs for liver disorders management. Indian Drugs. 1995;32:139–44.Google Scholar

  • [24]

    Rajesh MG, Latha MS Preliminary evaluation of the antihepatotoxic activity of Kamilari, a polyherbal formulation. J Ethnopharmacol 2004;91:99.PubMedCrossrefGoogle Scholar

  • [25]

    Jaeschke H. Reactive oxygen and mechanisms of inflammatory liver injury: present concepts. J Gastroenterol Hepatol 2011;26:173–9.PubMedWeb of ScienceCrossrefGoogle Scholar

  • [26]

    Wang T, Sun NL, Zhang WD, Li HL, Lu GC, Yuan BJ, et al. Protective effects of dehydrocavidine on carbon tetrachloride-induced acute hepatotoxicity in rats. J Ethnopharmacol 2008;117:300–8.PubMedWeb of ScienceCrossrefGoogle Scholar

  • [27]

    ICH guidelines, Analytical method validation (Q3). Geneva, 2000.Google Scholar

  • [28]

    ICH. Validation of analytical procedures and methodology, in Proceedings of the International Conference on Harmonization, Geneva, Switzerland, 2005.Google Scholar

  • [29]

    Pharmacopoeia U.S. USP-NF <1225> Validation of Compendial Methods. USP 32-NF27. 2009.Google Scholar

  • [30]

    FDA guidance for industry, Analytical procedure and method validation for drugs and biologics, Food and Drug administrator, 2015.Google Scholar

  • [31]

    Rustichelli D, Castiglia S, Gunetti M. Validation of analytical methods in compliance with good manufacturing practice: a practical approach. J Trans Med 2013;11:197–210.CrossrefGoogle Scholar

  • [32]

    Pasbola K, Chaudhary M. Updated review on analytical method development and validation by HPLC. World J Pharm Pharm Sci 2017;6:1612–30.Google Scholar

  • [33]

    Belouafa S, Habti F, Benhar S, Belafkih B, Tayane S, Hamdouch S, et al. Statistical tools and approaches to validate analytical methods: methodology and practical examples. Int J Metrol Qual Eng 2017;8:1–10.Google Scholar

About the article

Received: 2018-09-04

Accepted: 2018-10-07

Published Online: 2019-03-13

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Conflict of interest: None declared.

Citation Information: Journal of Complementary and Integrative Medicine, 20180159, ISSN (Online) 1553-3840, DOI: https://doi.org/10.1515/jcim-2018-0159.

Export Citation

© 2019 Walter de Gruyter GmbH, Berlin/Boston.Get Permission

Comments (0)

Please log in or register to comment.
Log in