Definition:- Standardization of drugs means confirmation of its identity, determination of its quality, purity and detection of nature of adulterant by various parameters like morphological, microscopical, physical, chemical and biological evaluations.
Standardization of herbal formulations include:-
- Quality evaluation of ingredients or quality control of crude drugs, finished preparations.
- Assessment of Stability (Shelf life evaluation based on physico-chemical, microbial and HPTLC/HPLC finger prints)
- Assessment of safety (Toxicological data and documented experience)
- Assessment of efficacy (Pharmacological screening data and documented traditional use)
The Standardization of crude drug materials includes :-
1. Authentication: – Each and every step has to be authenticated.
a) Stage of collection.
b) Parts of the plant collected.
c) Regional status.
d) Botanical identity like phytomorphology, microscopical and
histological analysis (characteristic of cell walls, cell contents, starch
grains, calcium oxalate crystals, trichomes, fibers, vessels etc).
2. Foreign matter (herbs collected should be free from soil, insect parts or
3. Organoleptic evaluation (sensory characters – taste, appearance, odor,
feel of the drug)
4. Tissues of diagnostic importance present in the drug powder.
5. Ash values and extractive values.
6. Volatile matter
7. Moisture content determination
8. Chromatographic (TLC, HPTLC, HPLC) and spectroscopic evaluation will
provide qualitative and semi quantitative information about the main
active constituents present in the crude drug as chemical markers in the
TLC fingerprint evaluation of herbals (FEH). On the basis of the
chromatographic fingerprint the quality of the drug can also be assessed.
9. Determination of heavy metals – e.g. cadmium, lead, arsenic, etc.
10. Pesticide residue – Limits of pesticides, which are usually present in the
herbs set by WHO and FAO (Food and Agricultural Organization).
Pesticides like DDT, BHC, aldrin, toxaphene are mixed with the herbs
during the time of cultivation cause serious side-effects in human beings.
11. Microbial contamination – usually medicinal plants containing bacteria
and molds are coming from soil and atmosphere. The substance known
as afflatoxins will produce serious side-effects if consumed along with the
12. Radioactive contamination – Irradiation usually avoids microbial
growth in herbals. This process may sterilize the plant material but the
radioactivity hazard should be taken into account.
Herbal drug standardization includes
a) Pharmacognostical Evaluation
b) Physico-chemical Evaluation
- Ash Values
- Optical Rotation
- Specific Gravity
- Disintegration Time
- Elemental Composition
c) Phytochemical protocols
- Extractive Values
- Chemical Profiling
- TLC Fingerprinting
- HPTLC / HPLC Based Quantifications
d) Residual analysis
- Heavy Metals