Seminar on ANALYTICAL
PARAMETERS IN AVALEHA
KALPANA
By
Dr. Priyanka Patil
MD(Ayu)
Dept of RS & BK

क्वाथादीनाां पुनः पाकात् घनत्वां सा रसक्रिया
सोÅवलेह्श्च लेह्शः स्यात् तन्मात्रा स्यात्पलोलोमन्मता
-शा म ख ८/१

The kashaya, svarasa or any other liquid
preparation is prepared
The sweetening agents like Guda, Sharkara
or Khanda sharkara are dissolved in liquid
preparations over mild fire
The blend may be filtered to get
rid of physical impurities
The filtrate is reboiled and
reduced to consistency of 1 to 2
threads.

 Ghee is added just before paka lakshana stage
Dose : 1 pala
Shelf life : upto 1 year
As avaleha paka lakshana are attained, prakshepa
dravya are added & stirred well
Honey should be added after the preparation
becomes completely cool and it is packed,stored in
Air tight container

 Any product requires certain analytical standards or parameters. These are
more essential, particularly in case of drugs and formulations.
 The formulations may be single drug preparation or a compound
preparation the analytical parameters are must. However, parameters
required for different preparation may be different. Analytical standards are
the dimensions to evaluate a product.
 It is compulsory to describe a product by analytical standards since these
standards speak of quality, authenticity and purity of the product.
 In India there are about 9000 ayurvedic pharmacies are working and
preparing ayurvedic medicines, among these most of them prepare low
quality and do not give expected results.
 so to provide standard value ,to provide quality control, safety and efficacy
of Ayurvedic formulations STANDARDIZATION IS essential tool.
 Certain parameters are necessary for raw drugs, procedures and end
products to provide quality assurance.

 Standardization is classified in 3 steps
• Standardization of raw
drugs
Step 1
• Standardization of
process/SOP
Step 2
• Standardization of
finished products
(ANALYTICAL
PARAMETERS)
Step 3

 1. Description
 Colour
 Odour
 Taste
 2. Loss on drying at 105 C
 3. Total – ash
 4. Acid – insoluble ash
 5. pH
 6. Total solid
 7. Fat content
 8. Reducing sugar
 9. Total sugar
 10. Identifications, TLC/HPTLC
 11. Test for heavy metals
 Lead
 Cadmium
 Mercury
 Arsenic

 12. Microbial contamination
 Total bacterial count
 Total fungal count
 13. Test for specific Pathogen
 E. coli
 Salmonella spp.
 S.aureus
 Pseudomonas aeruginosa
 14. Pesticide residue
 Organochlorine pesticides
 Organophosphorus pesticides
 Pyrethroids
 15 Test for Aflatoxins (B1,B2,G1,G2)

 Description : Semisolid sticky paste
 Colour: Usually Blackish Brown
 Odour : Pleasant
 Taste : Bitter, Astringent, Spicy

 To the crucible containing total ash, add 25 ml of dilute
hydrochloric acid. Collect the insoluble matter on an ashless
filter paper (Whatman 41) and wash with hot water until the
filtrate is neutral. Transfer the filter paper containing the
insoluble matter to the original crucible, dry on a hot-plate and
ignite to constant weight. Allow the residue to cool in a
suitable desiccator for 30 minutes and weigh without delay.
Calculate the content of acid-insoluble ash with reference to
the air-dried drug.

 Boil the ash for 5 minutes with 25 ml of water; collect
insoluble matter in a Gooch crucible or on an ashless filter
paper, wash with hot water, and ignite for 15 minutes at a
temperature not exceeding 450. Subtract the weight of the
insoluble matter from the weight of the ash; the difference in
weight represents the water-soluble ash. Calculate the
percentage of water-soluble ash with reference to the air-dried
drug.

 Incinerate about 2 to 3 g accurately weighed, of the
ground drug in a tared platinum or silica dish at a
temperature not exceeding 450c until free from carbon,
cool and weigh. If a carbon free ash cannot be obtained
in this way, exhaust the charred mass with hot water,
collect the residue on an ash less filter paper, incinerate
the residue and filter , add the filtrate, evaporate to
dryness, and ignite at a temperature not exceeding 450.
Calculate the percentage of ash with reference to the
air-dried drug.

 Procedure set forth here determines the amount of volatile matter (i.e.,
water drying off from the drug). For substances appearing to contain water
as the only volatile constituent, the procedure given below, is appropriately
used.
 Place about 10 g of drug (without preliminary drying) after accurately
weighing (accurately weighed to within 0.01 g) it in a tared evaporating
dish. For example, for un ground or un powdered drug, prepare about 10 g
of the sample by cutting shredding so that the parts are about 3 mm in
thickness. Seeds and fruits, smaller than 3 mm should be cracked. Avoid
the use of high speed mills in preparing the samples, and exercise care that
no appreciable amount of moisture is lost during preparation and that the
portion taken is representative of the official sample. After placing the
above said amount of the drug in the tared evaporating dish, dry at 105 for
5 hours, and weigh. Continue the drying and weighing at one hour interval
until difference between two successive weighing corresponds to not more
than 0.25 per cent. Constant weight is reached when two consecutive
weighing after drying for 30 minutes and cooling for 30 minutes in a
desiccator, show not more than 0.01 g difference

pH
 Defined as the common logarithm of the
reciprocal of the hydrogen ion concentration
expressed in g per liter.
 It can be determined potentiometrically by means
of the glass electrode, a reference electrode and a
pH meter either of the digital or analogue type.

Extract accurately weighed air dried sample
with petroleum ether (40-600C) in Soxhlet
apparatus. Dry the extract over anhydrous
sodium sulphate and remove the solvent
under vacuum at 400C. Weigh the residue and
calculate the percentage with reference to the
weight of sample material used.

 20 ml. sample was taken in a glass beaker to which the
clarifying agent, 10% lead acetate solution, was added
and warmed for about 3-5 minutes to get the
precipitate. Solution was filtered through brown paper.
To the filtrate sodium oxalate was added to dissolve
excessive lead acetate and to get a clear solution. This
solution was filtered through the filter bed made up of
glass wool, cotton and Whattman no. 1 filter paper to
get a clear solution, washing was given by distilled
water and the volume was made up to 250 ml

 20 ml. of solution, 20 ml. each of Fehling’s A and Fehling’s B solutions
were added, boiled for three minutes and filtered through filter bed (glass
wool, cotton and Whattman no. 1 filter paper). Repeated washing was
given by hot distilled water till clear, colourless filtrate was obtained.
Precipitate of cuprous oxide (residue) was then taken with acid ferric
solution to dissolve the precipitate completely in it. This solution was
titrated against KMnO4 using ortho phenanthrolin as indicator. At the end
point the brownish solution changes to green. From the amount of KMnO4
solution required the amount of copper was calculated. Then percentage of
sugar content was determined from Hammond table.

 25 ml of the clarified solution was taken; to it 5 ml of 6N HCl
was added and heated on water bath at 67-71°C. Then treated
with concentrated NaOH by using phenolphthalein as indicator
till pink colour appeared. Volume was made upto 100 ml. For
the determination of total sugar 20 ml. of this solution was
taken and the remaining procedure is the same as that of
reducing sugar. Percentage of total sugar was calculated from
Hammond table.

 Determination of non-reducing sugar : The
non-reducing sugar content was obtained by
subtracting reducing sugar from total sugar.
(Non reducing sugar = Total sugar – reducing
sugar.)

A technique in which solute undergo distribution
between two phases
i) Stationary phase-acting through adsorption
ii) Mobile phase in the form of liquid.
Identification can be effected by observation of
spots of identical Rf value and about equal
magnitude obtained, respectively, with an
unknown and a reference sample
chromatographic on the same plate. A visual
comparison of the size and intensity of the spots
usually serves for semi-quantitative estimation.

 Preparation of plates
 Application of solution
 Developing the plates
 Drying the plates
 Visualization at 264nm or 365nm

 The following tests are designed for the estimation of the
number of visible aerobic micro-organisms present and for
detecting the presence of designated microbial species in
pharmaceutical substances. The term 'growth' is used to
designate the presence and presumed proliferation of viable
micro-organisms.

Parameter Specifications
Total bacterial count 1 X 105 CFU/g
Yeast & mould 1 X 103 CFU/g
E.Coli Absent
Salmonella Absent
P. Aeruginosa Absent
S. Aureus Absent
2. Pesticide residue – organo-chloro
group
Less than 1 ppm
3.Heavy metals
Lead 10 ppm
Mercury 01 ppm
Arsenic 03 ppm
Cadmium 0.3 ppm
4.Aflatoxin B1 – 0.5 ppm
G1 – 0.5 ppm
B2 – 0.1 ppm
G2 – 0.1 ppm

 Pharmacognostical & physicochemical Analysis
of Musta-Triphaladi Avalehya, used in the
management of Thalassemia Major-IJAM
 Kalawana , Harisha CR , Rajagopala S Patel KS ,
Kori VK
 PG Scholar, Assistant Professor, Professor and
Head of the Department of Kaumarbhritya
,Pharmacognosy Laboratory
 I.P.G.T.&R.A., Gujarat Ayurved University,
Jamnagar, Gujarat, India.361008

Parameters Musta triphaladi avaleha
Loss on drying at 110◦C 11.094 % w/w
pH Value 6.0
Water soluble extractive 76.29 % w/w
Alcohol soluble extractive 83.65 % w/w
Ash Value 0.142 g
Acid insoluble Ash 0.193%

STANDARDIZATION OF POLY HERBAL AYURVEDIC
FORMULATION –VYAGHRI HARITAKI AVALEHA
WITH CLASSICAL VIEW POINT – IJRP
by
RAM PRAKASH,BHAGEL M.S,SHUKLA V.J
IGPT & RA ,JAMNAGAR,GUJARAT

Parameter API Parameters Gujarat ayurveda
university
Loss on drying at 105 NMT 23% w/w 18.40 %
Ash value NMT 4% W/W 2.86%
Water soluble extract NLT 68.7 % W/W 55.00%
Methanol soluble
extract
NLT 20% W/W 48.91%
Acid insoluble
extract
NMT 0.15% W/W 0.29%
pH 5.5- 6 5.0
Sulphated ash NMT 0.41% W/W 5.01%

 No doubt that analytical parameters are last step in standardization of
pharmaceutical preparations, but standardization of raw material by pharma
cognostical methods and following the standard methods of preparation
are the prior steps which play an important role in the quality of the end
product.
 Increased demand for Raw materials, decreased production of raw
materials due to deforestation and urbanization of the land ,the out come of
prepared medicine is of low quality, to over come from this problem
,analytical parameters are essential.
 The therapeutic effect depends on the quality of the drug administered. To
obtain the expected outcome after administration on particular disease,
especially a combined drug formula all ingredients should be present in it,
this can be confirmed with the help of these analytical parameters.
 Many classical preparations are yet to be standardized which are used in
day to day practice.