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J Complement Integr Med. 2019 Mar 13. pii: /j/jcim.ahead-of-print/jcim-2018-0159/jcim-2018-0159.xml. doi: 10.1515/jcim-2018-0159. [Epub ahead of print]

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

Author information

1
Multidisciplinary Research Unit, University Centre of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, India.

Abstract

Background 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. Methods 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. Results 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). Conclusions 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:

ICH guidelines; ayurvedic hepatic formulations; organic volatile impurities

PMID:
30870142
DOI:
10.1515/jcim-2018-0159

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