COMPARATIVE STANDARDIZATION STUDY OF GANDHARVA HARITAKI CHURNA FORMULATION
HTML Full TextCOMPARATIVE STANDARDIZATION STUDY OF GANDHARVA HARITAKI CHURNA FORMULATION
D. K. Kadam * 1, P. D. Ahire 2, J. V. Bhoye 2, A. R. Patil 2 and D. K. Yadav 2
KCT’s R.G. Sapkal College of Pharmacy 1, Sapkal Knowledge Hub, Anjaneri, Tryambakeshwar Road, Nashik - 422213, Maharashtra, India.
NGSPM’s College of Pharmacy 2, Brahma Valley Educational Campus, Tryambakeshwar Road, Anjaneri, Nashik - 422213, Maharashtra, India.
ABSTRACT: Standardization is the need of the hour in Ayurvedic system of medicine. The traditional systems of medicine are really effective but the problem with them is they lack in quality assurance. This enables us to recognise the quality of the formulation. The Central Council of Research in Ayurveda and Siddha has prescribed the preliminary guidelines for testing the quality of these formulations. It is essential to derive a protocol or develop methods for evaluation of herbal formulation to maintain uniformity between batches during production. The present work aims to standardize a poly-herbal churna called Gandharva haritaki Churna available in the market. The churna was procured and standardised for the parameters like organoleptic characters, physical characters, physiochemical properties and phytochemical screening etc. These parameters can determine the quality of the product. The results were found to be within the standards.
Keywords: |
Churna, Polyherbal, Ayurveda, Standardisation, Evaluation
INTRODUCTION:
Introduction of the Sample: Ayurvedic science has got its rich heritage in India. People in India believe that natural products are safe compared to synthetic drugs. The development in these traditional systems of medicine leads to maintain proper quality of the product. India is rich in its flora and fauna 1. These plants are being used for curing many diseases as such in raw condition rather the being prepared as formulation; standardisation is an essential parameter to be done.
It is a vital step in formulation since it determines the quality of the product and is essential to develop a protocol on standardisation of every product available in the market to avoid variation arising between batch to batch 2.
FIG. 1: SAMPLE NO. 1 GANDHARVA HARITAKI CHURNA
Plant materials are not like synthetic drugs, they vary in many conditions even in their chemical content depending on the time and season of collection of plant material, the geographical location of the plant being grown etc. 3
The CCRAS and WHO has introduced certain standards and guidelines to maintain uniformity between the production batches. Good manufacturing practices and quality control of the ingredients and products can result in ensuring quality assurance of the formulation 4.
FIG. 2: SAMPLE NO. 2 LAB MADE GANDHARVA HARITAKI CHURNA
The present study is to standardise a poly-herbal formulation available in the market called as Gandharva haritaki Churna used to treat many ailments of the body. The churna is evaluated for organoleptic properties, physical properties, physiochemical parameters and phytochemical screening to standardise the same.
MATERIALS AND METHODS: Gandharva haritaki Churna was selected because it had no previous specific scientific works been reported. So to prepare the standardisation procedures of the churna 5, 6, the present work was attempted. Gandharva haritaki Churna was procured from local market.
Organoleptic Evaluation: The colour, odour and taste of the formulation were evaluated manually Table 1.
TABLE 1: ORGANOLEPTIC ANALYSIS
S.
no. |
Parameters | Observation for Marketed Churna | Observation for Lab Made Churna |
1 | Odour | Characteristic | Characteristics |
2 | Taste | Astringent | Astringent |
3 | Colour | Light Yellowish | Light Yellowish |
4 | Texture | Fine | Fine |
Physico-chemical Parameters: Loss on drying, ash values, extracting values, pH and crude fibre content 7 was determined for the physicochemical parameters Table 2.
TABLE 2: PHYSICOCHEMICAL EVALUATION
S. no. | Parameters | Observation for Marketed Churna | Observation for Lab made Churna |
1 | LOD (%) | 1.8 | 2.5 |
2 | pH 1% & 10% w/w | 6 (acidic) | 6 (acidic) |
3 | Total ash value (% w/w) | 6.35 | 7.57 |
4 | Acid insoluble ash value (% w/w) | 3.4 | 3.18 |
5 | Water soluble ash value (% w/w) | 3.5 | 3.58 |
6 | Crude fibre content (g) | 4.2 | 3.5 |
7 | Alcohol soluble extractive value (% w/w) | 1.52 | 1.2 |
8 | Water soluble extractive value(% w/w) | 3.24 | 3.0 |
Loss on Drying: 2g of the churna was accurately weighed and transferred into a pre-weighed watch glass 8. This was dried at 105 °C for 5 hrs with regular check of weight for every interval. The final loss in weight was calculated by
LOD (%) = initial – final/initial × 100
pH: pH of the churna was determined using pH meter by dispersing 1% w/v and 10% w/v churna in water.
Crude Fibre Content: 2g of the churna wad added with 50ml of 10% nitric acid. This was boiled and filtered. The retains was washed with hot water and added with 50ml of 2.5% v/v sodium hydroxide solution. This was again filtered, washed with hot water and the residue was transferred into a crucible. The weight of the residue was taken for determining the crude fibre present in the churna.
Ash Value: Total Ash Value: The total ash content was determined by taking 2g of churna into a pre-weighed and tarred crucible and incinerated at a temperature not exceeding 450 °C, cooled and weighed. The difference between initial and final gives the total ash value 9.
Acid Insoluble Ash: The residue of ash obtained in total ash was added with 25 ml of dilute HCl and boiled for 5 min. This was filtered using ashless filter paper and ignited again to determine the acid insoluble ash.
Water Soluble Ash Value: The residue of the total ash was added with 25 ml of water in the place of dil. HCl and the procedure was followed the similar way.
Extractive Value: 10
Alcohol Soluble Extractive Value: 5g of churna was added with 100ml of alcohol and kept for 24 hrs, occasionally shaking and left aside after the first 6 h. It was then filtered. The filtrate was evaporated until constant weight was obtained. The difference in weight gives alcohol soluble extractive value.
Water Soluble Extractive Value: 11 5g of churna was added with 100ml of chloroform water and kept for 24 h and the similar procedure was followed like alcohol soluble extractive value.
Physical Characteristics of Churna: 12 Bulk density, Angle of repose, Hausner’s ratio, Carr’s index, and particle size distribution was determined for evaluating the physical characteristics of the churna Table 3.
TABLE 3: PHYSICAL EVALUATION
S. no. | Parameters | Observation for marketed Churna | Observation for Lab made Churna |
1 | Bulk density (g/ml) | 0.555 | 0.55 |
2 | Tapped density (g/ml) | 0.80 | 0.71 |
3 | Angle of Repose (θ°) | 35.75 | 33.42 |
4 | Compressibility index (%) | 30.625 | 22.53 |
5 | Hausner’s ratio | 1.44 | 0.16 |
Bulk Density: 10 g of churna was taken in a graduated measuring cylinder and tapped on a wooden surface. Bulk density is calculated by using the formula.
Bulk density = weight taken / bulk volume
Tap density = weight of churna taken / volume (tapped)
Angle of Repose: Angle of repose was determined by using funnel method. The powder was allowed to flow through a funnel fixed on a stand to form a heap. The height and the radius give the angle of repose.
Angle of repose tan θ = h / r
θ = tan-1 (h/r)
Where, h = height of heap; r = radius of heap.
Compressibility / Carr’s Index: This is calculated using the formula:
Compressibility / Carr’s Index = Bulk density (Tapped) − Bulk density (Untapped)/ Bulk density (Tapped) ×100
Hausner’s Ratio: The formula used to determine Hausner’s ratio is
Hausner’s ratio = Bulk density (Tapped) / Bulk density (untapped)
Fluorescence Analysis: A little amount of churna was macerated with a small quantity of solvents like 1N Sulphuric acid, 1N Nitric acid, 1N Hydrochloric acid, Iodine, Potassium hydroxide, Ammonia, 1N Sodium hydroxide for an hour and then filtered.
The filtrate was then analysed under day light and UV light for colour and fluorescence 13 Table 4 and 5.
Qualitative Phytochemical Screening: 15-17
Detection of Tannins: 2-3 ml of aqueous or alcoholic extract of powders were tested carefully with various tannins test reagents as
- 5% FeCl3 Solution: A deep blue-black colour indicates the test is positive.
- Lead Acetate Solution: A white precipitate indicates the test is positive.
- Bromine Water: Deceleration of bromine water indicates the test is positive.
Dilute Iodine Solution: Transient red colour indicates the test is positive.
TABLE 4: FLUORESCENCE ANALYSIS FOR SAMPLE 1
Solvent added | Colour observed under | ||
Day light | Short UV wavelength (256 nm) | Long UV wavelength (365 nm) | |
1N Sulphuric acid | Light brown | Light green | Dark Green |
1N Nitric acid | Light brown | Light green | Dark Green |
1N Hydrochloric acid | Light brown | Light green | Dark Green |
Iodine | Greenish brown | Dark green | Dark bluish |
Potassium hydroxide | Light Brown | Green | Light bluish |
Ammonia | Light Brown | Green | Light bluish |
1N Sodium hydroxide | Brown | Dark green | Dark bluish |
TABLE 5: FLUORESCENCE ANALYSIS FOR SAMPLE 2
Solvent added | Colour observed under | ||
Day light | Short UV wavelength (256 nm) | Long UV wavelength (365 nm) | |
1N Sulphuric acid | Light brown | Light green | Green |
1N Nitric acid | Light brown | Light green | Green |
1N Hydrochloric acid | Light brown | Light green | Green |
Iodine | Greenish brown | Dark green | Dark bluish |
Potassium hydroxide | Light Brown | Green | Light bluish |
Ammonia | Light Brown | Green | Dark green |
1N Sodium hydroxide | Brown | Dark green | Dark bluish |
TABLE 6: HEAVY METALS TEST 14
Test | Observation | Inference | |
For Cadmium
|
NH4OH added in the sample solution | White ppt. of cadmium hydroxide soluble in excess NH4OH | Presence of cadmium |
Potassium ferrocyanide added | White ppt. of cadmium ferrocyanide. | Presence of cadmium | |
For Bismuth
|
H2S gas added in the sample solution | Dark brown ppt. soluble in hot dil. HNO3 but insoluble in NH4S | Presence of bismuth |
NH4OH | White ppt. insoluble in excess NH4OH dissolved in dil. HCl | Presence of bismuth | |
For Lead
|
Dil. HCl added in sample solution | White ppt. of CaCl2 soluble in boiled water and conc. HCl | Presence of lead
|
KI is added in sample solution | Yellow ppt. soluble in boiling water | Presence of lead |
TABLE 7: HEAVY METAL ANALYSIS
Test | Observation | Result | |
Test for cadmium | NH4OH added in the sample solution. | White ppt. is absent | Absence of cadmium |
Potassium ferrocyanide added | White ppt. is absent | Absence of cadmium | |
Test for bismuth | H2S gas added in the sample solution | Dark brown ppt. is absent | Absence of bismuth |
NH4OH | White ppt. is absent | Absence of bismuth | |
Test for lead | Dil. HCl added in sample solution | White ppt. of CaCl2 is absent | Absence of lead |
KI is added in sample solution | Yellow ppt. is absent | Absence of lead |
TABLE 8: QUALITATIVE PHYTOCHEMICAL SCREENING
Test | Sample 1 | Sample 2 | |
Test of Tannin | 5% FeCl3 solution | Positive | Positive |
Lead acetate solution | Positive | Positive | |
Bromine water | Positive | Positive | |
Dilute iodine solution | Positive | Positive | |
Test for Alkaloids | Dragendroff’s test | Positive | Positive |
Wagner’s test | Positive | Positive | |
Mayer’ test | Positive | Positive |
Detection of Alkaloids: 50 mg of solvent free extract was hydrolysed with dil. HCl and filtered. The filtrates were tested carefully with various alkaloid test reagents as follows.
Dragendroff’s Test: To a few ml of filtrates, 1 to 2 ml of Dragendroff’s reagent was added. A prominent yellow precipitate indicates the test is positive.
Wagner’s Test: To a few ml of filtrates, few drops of Wagner’s reagent were added by the side of the test tube. A reddish-brown precipitate confirms the test as positive.
Mayer’s Test: To a few ml of filtrates, few drops of Mayer’s reagent were added by the side of the test tube. A white or creamy precipitate if obtained indicates the presence of alkaloids.
RESULTS AND DISCUSSION: The churna was procured and was evaluated for its organoleptic, physical, physicochemical and fluorescence analysis. All the results obtained have been tabulated.
CONCLUSION: From the present investigation various standardization parameters such as physicochemical standards like total ash, acid insoluble ash, water and alcohol soluble extractive values, loss on drying, phytochemical analysis, flow properties and safety evaluation were carried out, it can be concluded that the formulation of Gandharva haritaki churna contains all good characters of an ideal churna and it was found to be harmless, more effective, and economic. The comparison between the one marketed sample and lab made churna have been done on the basis of the above mentioned parameters which shows satisfactory results, but the efficacy of the products can only be judged by doing the pharmacology of which is suggested as future scope of R & D.
ACKNOWLEDGEMENT: Nil
CONFLICT OF INTEREST: Nil
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How to cite this article:
Kadam DK, Ahire PD, Bhoye JV, Patil AR and Yadav DK: Comparative standardization study of gandharva haritaki churna formulation. Int J Pharmacognosy 2017; 4(7): 245-49. doi link: http://dx.doi.org/10.13040/IJPSR.0975-8232.IJP.4(7).245-49.
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Article Information
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English
IJP
D. K. Kadam *, P. D. Ahire, J. V. Bhoye, A. R. Patil and D. K. Yadav
KCT’s R.G. Sapkal College of Pharmacy, Sapkal Knowledge Hub, Anjaneri, Tryambakeshwar Road, Nashik, Maharashtra, India.
deepalikadam777@gmail.com
27 March 2017
22 May 2017
30 May 2017
10.13040/IJPSR.0975-8232.IJP.4(7).245-49
01 July 2017