Advance Pharmaceutical Journal 2018; 3(3):83-89 83

Review Article
Concise report on Standardization of herbal drugs and its products
Shuchi Mehta1, Ashish Garg2, Sweta Garg2, Manish Kumar3, Ajay Shukla3*
1
Department of Pharmacognosy, Guru Ramdas Khalsa Institute of Science & Technology Pharmacy, Jabalpur, India
2
Department of Chemistry and Pharmacy, Rani Durgavati University, Jabalpur, India
3
Department of Pharmaceutical Science, Mohanlal Sukhadia University, Udaipur Rajasthan, India

Received: 2 July 2018 Revised: 28 July 2018 Accepted: 14 August 2018

Abstract
Utilization of herbal drugs as medicine is the ancients' form of health care and it is used in all cultures all over history.
The primeval persons learned by trial and error basis to identified valuable plants. In modern times, more demand
increasing towards herbal products because herbal products having low toxicity as compare to other medicine and
there is increasing awareness and general acceptability of herbal drugs in today's medical practice. It is however a
known fact that over 80% of the world population used herbal medicines and product for healthy living. As well as
demand of herbal products increases the need of herbal quality assurance for customer satisfaction also increases.
For the prevention of drug adulteration and developed abuse herbal products, WHO have been released guidelines to
all herbal industries. The identification of this highly active moiety is an important requirement for Quality control
and dose determination of plant related dugs. Standardization of herbal drugs means confirmation or validation of its
purity, quality and identity. It is mandatory for every herbal industry. It must need for collection, handling, processing
and production of herbal medicine as well as employ such parameters in ensuring the safety and compulsory need for
the global herbal market. In this review covers all guidelines which are required for development of herbal products at
global scale. This review covers all quality control parameters.
Keywords: Herbal drugs, standardization, quality control

Introduction minerals that were not a part of usual diet. Primeval persons
The term “herbal drugs” word means by sources plant or part of learned by trial and error basis to identified beneficial
plants that are used for the treatment of various diseases, in plants with helpful effects from those that were inactive or
terms of phyto-pharmaceuticals. Firstly it collectcoll or toxic, and also which processing methods or mixtures had
harvesting, drying, storage and then isolated and used (EMEA to be used to meet steady and ideal results. Even in a ancient
et al., 1998). The use of herbal drugs as medicine in the earliest cultures ethnic, ancestral or tribal people collect
form of healthcare known to delicacy and it is used in all information related to herbal plant and developed which is
cultures throughout history. Ancient humans well known their defined herbal phrmacopeais (Kunle et al., 2012).
dependence on nature for a good healthy life and since that time The standardization of herbal drugs includes
humankind depended on the variety of plant resources for food, 1. Firstly Authentication of herbal drugs which includes
shelter, clothing and medicine to cure immensurable of collection, parts of the plant collected botanical
diseases. The first written records explaining the use of plant in identification by botanist.
the healing of Mesopotamian clay tablet writing and Egyptian
2. Removal of all Foreign matter (herbs collected should be
papyrus. Led by nature, taste and experience, primeval men
free from soil, insect parts or animal excreta, etc.)
and women cured illness by using plant parts, animal parts and
3. Determination of organoleptic evaluation of herbal drugs
*Address for Corresponding Author:
as (sensory characters – taste, appearance, odor, feel of the
Mr. Ajay Kumar Shukla
drug, etc.)
Department of Pharmaceutical Science, Mohanlal Sukhadia
University, Udaipur, Rajasthan, India 4. Tissues of diagnostic significance present in the drug
Email: ashukla1007@gmail.com powder.
DOI: https://doi.org/10.31024/apj.2018.3.3.3
2456-1436/Copyright © 2018, N.S. Memorial Scientific Research and Education Society. This is an open access article under the CC
BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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 Advance Pharmaceutical Journal 2018; 3(3):83-89 84

5. Determination of ash values and extractive values. world. In a number of communities herbal medicine is still a
6. Determination of volatile matter central part of their medical system. The World Health
Organization (WHO) has a provided of specific Guidelines
7. Determination of moisture content determination
for the evaluation of the safety, efficacy and Quality of
8. Chromatographic and spectroscopic evaluation. TLC, herbal medicinal drugs or herbal medicines. WHO find out
HPTLC, HPLC methods will provide qualitative and semi that 80% of the world people now use herbal medicine or
quantitative information about the main active constituents drugs, except in some countries herbal medicinal drugs may
present in the crude drug as chemical markers in the TLC also used by traditional, natural or in form of inorganic
fingerprint evaluation of herbals (FEH). The quality of the drug active constituents. Those are the not directly obtained from
can also be assessed on the basis of the chromatographic plant. An herbal medicinal drug is a main constituent in
fingerprint. usual medicine and a common ingredient in Homeopathic,
9. Determination of heavy metals – e.g. cadmium, lead, Ayurvedic, and Naturopathic and in other medicine system.
arsenic, etc. Herbs are regularly measured as safe toxicity, side effects of
allopathic drugs, has led to more increased in numeral of
10. Determination of pesticide residue – according to WHO and
herbal drugs manufacturers. For the past few years, herbal
FAO (Food and Agricultural Organization) set limits of
drugs have been mostly used by the citizens with no
pesticides, which are usually present in the herbal sources. These
prescription, Leaves, stem, bark, flower, seeds, roots and
pesticides are mixed with the herbs through the time of
extract of all these have been used in herbal medicinal drugs
cultivation. Mostly pesticides like DDT, BHC, toxaphene, aldrin
over the thousands of their use (Bhutani et al., 2003).
source serious side-effects in human beings if the crude drugs are
mixed with these agents. Official standards
11. Microbial contamination – generally medicinal plants The identification, purity and quality of herbal drugs are
having bacteria and molds are coming from soil and atmosphere. determined by reference given in a pharmacopoeia.
Determination of the limits of E. coli and molds clearly throws Pharmacopoeia prescribes like Analytical, physical and
light towards the harvesting and production practices. These structural standards for the herbal drugs. A significant
substance known as afflatoxins will produce serious side-effects identification and examination of crude drugs is important
if taken along with the crude drugs (Patil et al., 2011). in processes of herbal formulation because of more
diversity and changes in their chemical nature or characters.
Identification and standardization of herbal active
To reduce this problem all pharmacopeias have certain
compounds
standards. Specific test for specific plant material are given
The identification of purely herbal active moiety is a significant below. Alkaloids content dragendorff test, Fat content Acid
requirement for Quality control and dose purpose of plant value Iodine value, saponification value molish test
related dugs. A traditional herbal plant can be checked as an carbohyadrates Millon tests Amino acid Volatile oil
artificial laboratory as it produces and contains chemical Hemolytic activity Assay for Phosphate/Aluminium/
substances. Those substances, responsible for biological activity Camphor /Potassium /Lead/Iron/Gold/Calcium (Nikam et
of the herbal plant, are mostly secondary metabolites. for al., 2012; Pandey et al., 2016; Bodhisattwa et al., 2011). The
example, of Alkaloid constituents, are nitrogenous principle main objective of these guidelines is to contribute to the
organic moiety combine with acid to form crystalline salt and quality assurance of medicinal plant materials used as the
also herbal plants contains flavonoids, Resin, Oleoresins, source for herbal medicines, which aims to improve the
lactones, saponin and volatile oils. Investigation of quality, safety and efficacy of finished herbal products and
phytochemical screening of the medicinally herbs, not done in minimize the risks involved in any pharmaceutical
proper way in India. This would be useful in standardization and production that cannot be eliminated through testing the
dose determination of any herbal drugs (Waldesch et al., 2003; final product (WHO 2002).
Sharma et al., 2010). Herbal medicinal plant has played an
Diagrammatic presentation of various standardization and
important role in world health. They are dispersed worldwide,
evaluation parameters, using for the herbal products quality
but they are mainly rich in tropical countries. It is well-known
control as per WHO guidelines given in figure 1.
that about 25% of all modern medicines are indirectly or directly
came from herbal plants. The knowledge of herbal plant based Morphological or Organoleptic evaluation
drugs developed gradually and was passed on, therefore, laying It includes the evaluation of herbal medicinal drugs by size,
the basis for many systems of traditional medicine all over the shape color, odor, taste and particular characteristics like

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 Advance Pharmaceutical Journal 2018; 3(3):83-89 85

Figure 1. Standardization and quality evaluation of herbal drugs methods

touch, texture etc using sense of organs. This is a method of Some Microscopic Identification tests are given below
qualitative evaluation related to the study of morphological and (Pandey et al., 2013; WHO et al., 1988; Shukla et al., 2013).
sensory report of whole herbal drugs.eg. Fractured surfaces in 1. Starch test: Hemicellulose T.S. of Crude drug + 1 Drop of
cascara, cinchona, and quillia bark and quassia wood are Iodine Solution Blue color
essential individuality. Umbelliferous fruits have aromatic odour
2. Mucilage test: Ruthenium Red Pink color
and liquorice have sweet taste are the example of this type of
evaluation (Kokate et al., 2010; Ansari et al., 2011; Pandey et al., 3. Lignin test: Lignin T.S. of crude drug + 1 drop of
2013). phloroglucinol + 1 drop of HCL Pink color

Microscopic evaluation Chemical evaluation of herbal drugs

It is used to recognize the organized herbal drugs on the basis of The most of herbal drug contain definite chemical
their known histological characters. It is frequently used for constituents to which their pharmacological and Biological
qualitative analysis of organized crude drugs in total and powder activity depended. Qualitative chemical test used to
form with the help of microscope. The inner pseudoparenchyma recognize drug quality and purity. The identification,
cells are found round or oval shape. They contain mainly protein isolation and purification of active herbal chemical
and fixed oil. Crude drugs are microscopically identified by constituents is depends chemical methods of evaluation.
taking thin TS (Transverse section), LS (Longitudinal Section) in Preliminary phytochemical examination is also a part of
a bark, wood and leaf of plant. The different parameters included chemical evaluation. Some Qualitative chemical test for
in microscopy are given bellow. chemical evaluation herbal crude drug includes borntrager
test, dragendroff reagent etc. (Sharma et al., 2013; Pandey
I. Stomata II. Trichomes III. Leaf Content IV. Quantitative
et al., 2016; Shukla et al., 2013).
Microscopy

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 Advance Pharmaceutical Journal 2018; 3(3):83-89 86

Importance parameters of evaluation of herbal medicinal drugs W = Weight in mg of lycopodium taken.

1. Macro and microscopic assessment: For Identification of M= weight in mg of the sample
right variety and search of adulterants. P= number of characteristics particles per mg of the
2. Foreign organic matter assessment: This involves removal of pureforeign matter. 94,000= number of spores per mg of
matter other than source plant to get the drug in pure form lycopodium (WHO et al., 2004).
3. Determination of ash value: helpful in determining the Determination of Total Ash Value
quality and purity of crude drugs, especially in powder form. Used for determination of quality and purity of a crude
The objective of ashing vegetable drugs is to remove all herbal drug, using ash of herbal drug because they contains
traces of organic matter, which may otherwise interfere in an inorganic radicals like phosphates, carbonates and silicates
analytical determination. of sodium, Potassium, Magnesium and calcium.
4. Determination of moisture content: Checking moisture Sometimes, inorganic variables like calcium oxalate, silica,
content helps reduce errors in the estimation of the actual carbonate content of the crude drug like affects 'Total ash
weight of drug material. Low moisture suggests better value'. Such variables are then removed by treating through
stability against degradation of product. acid (as they are soluble in hydrochloric acid) and them acid
5. Determination of extractive values: These are indicative insoluble ash value is determined e. g. Rhubarb, Liquorice
weights of the extractable chemical constituents of crude etc. The residue after incineration is the total ash content of
drug under different solvents environment. the crude herbal drug, which simply represents inorganic
salts, naturally found in drug or adhering to it or deliberately
6. Determination of crude fibre: This helps to determine the
added to it, in the form of adulteration of herbal drugs.
woody material component, and it is a criterion for judging
purity. Two types of total Ash value mainly:

7. Determination of qualitative chemical evaluation: This 1. Water soluble Ash value 2. Acid-insoluble Ash value.
covers identification and characterization of crude drug with Determination of Extractive Values
respect to phytochemical constituent. It employs different The herbal extracts obtained by exhausting crude drugs are
analytical technique to detect and isolate the active indicative of approximate measure of their chemical
constituents. Phytochemical screening techniques involve constituents. The varieties of solvent are used for
botanical identification, extraction with suitable solvents, determination of extractives. These are classified as
purification, and characterization of the active constituents fallows.
of pharmaceutical importance.
1. Water soluble extractives values. 2. Alcohol Soluble
8. Determination of chromatographic examination: Include extractives values. 3. Ether Soluble extractives values.
identification of crude drug based on the use of major
Determination of heavy Metals
chemical constituents as markers
In general, quantitative and limit tests correctly determine
Determination of Foreign Matter
the concentration of heavy metals in the form of impurities
Herbal medicinal drugs should be prepared from the and contaminants. The heavy metals like Arsenic, mercury,
authenticated part of the plant. They should be totally free from lead, thalium, and cadmium have been exposed to be
insects or moulds, including visible and excreta contaminant contaminants of few herbal ingredients. A simple
such as stones, sand, harmful and poisonous foreign matter and determination of heavy metals, using pharmacopeias
chemical moieties. Animal objects such as insects and invisible methods and it is based on color reaction with special
microbial contaminants, which produce toxins, as well as the reagents such as diethyldithiocarbonate or thioacetamide
possible contaminants of herbal medicines. Macroscopic and amount is determined by comparison with a standards.
evaluation can easily used to determine the occurrence of The methods usually used for analysis are inductive
foreign matter, although microscopy is essential in certain coupled plasma (ICP), Netron activation analysis (NAA),
special cases for example starch intentionally added to “dilute” Atomic Absorption Spectrophotometry (AAS) etc (Watson
the herbal plant material (WHO et al., 2003). et al., 1999; WHO et al., 2007).
% of foreign Organic Matter = N × W × 94,100 × 100/S ×M × P Determination of Radioactive contamination
Where; n = No. of chart particles in 25 field. The microbial growth in herbal medicinal drugs is usually
S = No. of spores in the same area of 25 fields. avoided by irradiation. Dangerous contamination may be

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 Advance Pharmaceutical Journal 2018; 3(3):83-89 87

the result of a nuclear accident. The WHO, in close support with 2. In during process standardization
several other international organizations, has developed In during process standardization is the key method for the
guiding principle in the event of a wide spread contamination development of quality herbal products. So the standard
by radio nuclides resulting from major nuclear accidents. The operating process should be pursuing strictly, if other
nuclear accident in chernobyl and Fukushima may be severe substances are added in through manufacture in order to
and depend on the specific radionuclide, the stage of adjust the herbal formulations. A method for qualitative,
contamination and the quantity of the contaminant taken. quantitative and where possible, the assay of the plant
Examples of such radionuclides include extended lived and preparation should be added. If identification of a bioactive
short lived fission products, actinides and activation products principle is not possible, it should be sufficient to recognize
(28, AOAC et al., 2005; De Smet PAGM et al., 1992). a characteristic substance or mixture of herbal medicinal
Determination of pesticides residue substances to ensure consistent quality of the product.
Determination of pesticides residues are any particular 3. Finishing product
substance in food, agriculture commodities or animal feed Prepared finished product should have standard nature of
resulting from the use of pesticides. Herbal medicinal drugs are characteristics. All information associated to product
prone to hold pesticide residue, which gather from agricultural formula, including the exact amount of recipients, should be
practices, such as Spraying, behavior of soil during cultivation described in specify. A finished herbal product specification
and addition of fumigants during storage. The Pesticides should be defined to ensure and validated consistent quality
mainly contain chlorine in the molecules, which can be of the product. The finished herbal product should fulfill
determined by analysis of chlorine; insecticides containing with general requirements for particular dosage forms and
phosphate can be identify by measuring total organic quantity. The processes involves wide array of scientific
phosphorus. The varieties of methods are used to measure screening like as physical, chemical and biological
pesticides by GC, MS, OR GCMS. Some simple methods are evaluation employing various analytical methods and tools.
also published by the WHO and Europian pharmacopeia has in The specific object of such investigation in validate herbal
general limits for pesticides residue in herbal medicine (Bjaj et quality are as varied as the processes used. Analytical
al., 2012). Specifications of Herbal products followed as per
Determination of specific optical rotation (Shukla et al., requirement according to official monograph (WHO) and
2013) form of the medicine. Following mentioned different
Determination of Specific rotation formula -D25= 100 × φlc products specifications are (WHO et al., 1998; Calixto et al.,
2000):
Where: φ = corrected observed rotation in drug at-25°
 Examination of Colour, Odour
D = d line of sodium light
 Determination of total – ash
l = length of the polarimeter tube in done.
 Determination of acid – insoluble ash
c = concentration of substance in percent w/v.  Determination of water & Alcohol-soluble
Methods of Standardisation of Ayurvedic medicines extractive
1) Raw material standardization  Determination of viscosity

2) In process standardization  Determination of refractive index

 Determination of specific gravity at 250 C.
3) Finished product standardization
 Determination of alcohol content Test for
1. Raw material identification and standardization
methanol.
Under this process following parameters considered carefully.
 Determination of total acidity.
Area of the collection, parts of the plant, the regional situation,
 Determination of no. reducing and reducing sugar
botanical identity, microscopic and histological analysis,
taxonomic identity, Foreign matter, Loss on drying, swelling  Determination of PH
index, foaming index, ash values, extractive values,  Determination of total sugar content
Chromatographic, spectroscopic evaluation, Determination of  Determination of loss on drying at 105 ºC
heavy metals, pesticide residues, Microbial and Radioactive  Determination of particle size (80-100 mesh for
contamination proper way. Churna; 40- 60 mesh for Kvathachurna)

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 Advance Pharmaceutical Journal 2018; 3(3):83-89 88

 Determination of weight variation want to lead in market globally. Others consideration keep
 Determination of disintegration time -Not more than 15 maintain as related to quality of herbal drugs may need more
min complete information on aspects of herbal products. As the
variety of seeds, condition of cultivation and harvesting
 Identification test of TLC/HPTLC/GLC
represent an important aspect in producing a reproducible
 Determination of Assay quality of herbal medicinal products. Quality of herbal
 Determination of heavy/Toxic metals: Lead, products are depends on physical, chemical, biological
Cadmium, Mercury, Arsenic factors, hence assessment of these factors should be done,
validate and documented. This plays a very important role
 Determination of microbial contamination: Total
in the identification and purity of drug. All these parameters
bacterial count, Total fungal count
are mandatory for the development, validation and export
 Determination of specific Pathogen: E. coli, quality of herbal drugs.
Salmonella spp. S. aureus, Pseudomonas aeruginosa
Conclusion
 Determination of pesticide residue: Organochlorine
Ayurveda is one of the most famous oldest therapeutic
pest icides , Organophosphorus pesti cides,
systems that has nourished and flourished from earliest ages
Pyrethroids
till date. India can come into sight as the major country and
 Determination of aflatoxins (B1, B2, G1, G2) playing the lead role in improvement of standardized,
Advanced techniques and standardization of herbal drugs therapeutically effective ayurvedic formulation and
and its products development. India may explore to investigate the
Quality control of herbal preparation is a tedious and difficult medicinally importance of herbal plants. This can be
job. Hence in standardization process of herbal medicinal happen, only if the herbal formulated products are proper
drugs and its prepared formulations are now days analyzing by way evaluated and analyzed by using sophisticated
using hyphenated techniques based. Various advanced these hyphenated modern techniques like as UV spectroscopy,
technologies are HPLC, HPLC-MS, GC-MS and FTIR etc. TLC, HPLC, HPTLC, GC-MS, LC-MS
These modern and fingerprint analysis techniques is the most spectrofluorimetric and other methods. The determination
effective tool for quality control of herbal medicines because of general peaks in a set of chromatographic fingerprints
of its accuracy and more reliability. By these techniques that gives useful qualitative and quantitative analytical
determines the correct concentrations of potent bioactive information on the distinctive components of herbal
chemical constituents and a set of distinctive chemical medicines investigated. Consequently chromatographic
substances in herbal drugs. Knowing the relative fingerprint analysis provides potentially useful quality
concentrations is a means of assuring the best quality of herbal control tool for standardization of herbal medicines.
products have or not. It can serve as an important tool for Conflicts of interest: None
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