Quality Control methodologies for standardization of herbal medicines: an assessment

1. Quality Control methodologies for
standardization of herbal
medicines: an assessment
Raja Chakraverty
Scientist-C
ICMR-National Institute of Cholera and Enteric
Diseases, Kolkata.
Email: rchakraborty20@yahoo.com

2. Need for standardization
• Standardization as defined by American Herbal Product association:
“Standardization refers to the body of information and control
necessary to product material of reasonable consistency.
• Methods of standardization namely correct identity of the sample,
organoleptic evaluation, pharmacognostic evaluation, volatile
matter, quantitative evaluation (ash values, extractive values),
phytochemical evaluation, test for the presence of xenobiotics,
microbial load testing, toxicity testing, and biological activity.
• Of these, the phytochemical profile is of special significance since it
has a direct bearing on the activity of the herbal drugs.
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3. Procedures for standardization of
Herbal drugs
The following parameters are recommended:
1. Authentication
2. Physical parameters
3. Quantitative and Qualitative analysis
4. Microbiological contamination
5. Pesticide residue
6. Heavy metal analysis
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4. WHO Guidelines for Herbal drug
standardization
The subject of herbal drug standardization is very
important. The guidelines set by WHO is summarised as
follows:
• Reference to the identity of the drug
• Reference to the physicochemical character of the
drug
• Reference to the Pharmacological proerties.
• Toxicity details
• Microbiological parameters
• Radioactive contamination
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5. Standardization and evaluation of herbal drugs
(Bijaulia et al., 2017)
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6. Processes associated with herbal drug standardization
(Adopted from Lavania et al., 2017)
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7. Steps in the Quality control algorithm of herbal
medicines
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8. Stability testing of herbal medicines
Stability Testing of Herbal Products:
8.1 Analytical Methods for Herbal Products: The analysis of herbal preparations is mostly done
by running high performance liquid chromatography (HPLC) or gas chromatography (GC) and
thin layer chromatography (TLC) methods, quantitative determinations by UV visible
spectroscopy or combinations of these. HPLC and GC methods can be used for identification and
purity testing, as well as the detection of single compounds for assay, is possible during one
analysis. LC and GC mass coupling .
8.2 Shelf-Life: The determination of shelf life of herbal medicinal drug products is same as
chemically defined APIs, but special nature of herbal product should be taken into
consideration. It is recommended that in case of a herbal medicinal product containing a natural
product or a herbal drug preparation with constituents of known therapeutic activity, the
variation in component during the proposed shelf-life should not exceed ± 5% of the initial assay
value, unless justified to widen the range up to ±10 per cent or even higher. The low marker
concentration in the finished product, justify the wider range.
. Considering that the marker content cannot be defined to a specified level, the relative
changes from the starting value are specified (95-105 per cent or 90-110 per cent ‘from the
initial value).
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9. The way forward
• The Indian herbal industry is growing in a tremendous rate. More number of
herbal products has arrived in the market. The safety and efficacy of herbal
products are dependent upon the standardization of these herbal drugs. The
traditional approach towards standardization is insufficient for current herbal
market and hence there is need for more advanced techniques for standardization.
• The quality of herbal drugs is the sum of all factors which contribute directly or
indirectly to the safety, effectiveness and acceptability of the product. Due to
advancement in the chemical knowledge of crude drugs various methods like
botanical, chemical, spectroscopic and biological methods are used for estimating
active constituents present in the crude drugs. Standardization methods should
take into consideration all aspects contributing to the quality of the herbal drugs.
• The development of modern analytical tools in testing the various quality
parameters for an effective quality control herbal product cannot be over
emphasized. The assurance of the safety and efficacy of a herbal drug requires
monitoring of the quality of the product from collection through processing to the
finished packaged product.
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10. The hierarchy of standardization paradigms
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11. Thank you for your attention
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