E-ISSN:2456-3110

Research Article

Trayushnadi Gutika

Journal of Ayurveda and Integrated Medical Sciences

2025 Volume 10 Number 2 FEBRUARY
Publisherwww.maharshicharaka.in

Pharmaceutical Standardization and Analytical Evaluation of different samples of Trayushnadi Gutika

Roy P1*, Kumar Dwivedi P2
DOI:10.21760/jaims.10.2.12

1* Priyanka Roy, MD in Rasashastra and Bhajshajya Kalpana, Govt Ayurvedic College and Hospital, Patna, Bihar and Ayurvedic Medical Officer, APHC Sahebpur Kamal, Begusarai, Bihar, India.

2 Prabhat Kumar Dwivedi, Professor, Dept of Rasashastra and Bhajshajya Kalpana, Govt Ayurvedic College and Hospital, Patna, Bihar, India.

Introduction: Ayurvedic pharmaceutics (Rasashastra) emphasizes the purification and formulation of mineral- and metal-based drugs to enhance therapeutic efficacy and bioavailability. Trayushnadi Gutika is a classical formulation requiring rigorous standardization for quality, safety, and efficacy. With increasing commercial demand and large-scale manufacturing, concerns arise regarding ingredient authenticity and pharmaceutical integrity. This study focuses on ensuring the standardization of Trayushnadi Gutika using traditional and modern analytical methods.

Methods: Pharmaceutico - analytical study of both sample of Trayushnadi Gutika and its ingredients were carried out at Nagarjuna Laboratory, Department of Rasashastra and Bhaishajya Kalpana, Government Ayurvedic College, Patna, Bihar. Raw materials were authenticated based on Grahya Lakshana (acceptable characteristics) from classical texts. Pharmaceutical processing techniques were evaluated to ensure uniformity in formulation. Physicochemical analysis, including organoleptic characteristics, pH, moisture content, and other relevant parameters, was performed to assess the quality of the final product.

Results: The analysis confirmed the authenticity and purity of raw materials used in Trayushnadi Gutika. Pharmaceutical processing evaluations indicated consistent formulation techniques across batches. Physicochemical assessments showed that the product met standard criteria for Ayurvedic formulations, ensuring therapeutic efficacy and stability.

Discussion: This study highlights the importance of maintaining raw material authenticity and uniform manufacturing processes to ensure the efficacy of Ayurvedic formulations. By integrating traditional standardization techniques with modern analytical methods, Trayushnadi Gutika can be produced with consistent quality and reliability. Strengthening pharmaceutical standardization practices will enhance confidence in Ayurvedic therapeutics and promote its broader acceptance.

Keywords: Ayurvedic pharmaceutics, Trayushnadi Gutika, Rasashastra, Pharmaceutical standardization, Physicochemical analysis, Ayurvedic drug formulation, Traditional medicine, Herbal standardization.

Corresponding Author How to Cite this Article To Browse
Priyanka Roy, MD in Rasashastra and Bhajshajya Kalpana, , Govt Ayurvedic College and Hospital, Patna, Bihar and Ayurvedic Medical Officer, APHC Sahebpur Kamal, Begusarai, Bihar, India.
Email: 		Roy P, Kumar Dwivedi P, Pharmaceutical Standardization and Analytical Evaluation of different samples of Trayushnadi Gutika. J Ayu Int Med Sci. 2025;10(2):78-90.
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https://jaims.in/jaims/article/view/4306/

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2025-01-13 2025-01-23 2025-02-03 2025-02-13 2025-02-23
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None Nill Yes 13.36

© 2025by Roy P, Kumar Dwivedi Pand Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

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Download PDFBack To ArticleIntroductionAim and ObjectivesMaterials and MethodsObservations and ResultsDiscussionConclusionReferences
Priyanka R et al. Pharmaceutical Standardization of Trayushnadi Gutika

Introduction

Rasashastra the unique Ayurvedic Pharmaceutics which deals with the preparation of drugs from metals, minerals, poisonous herbal drugs and animal products, these are rarely administered in their crude form.

And these are often combined with a number of substances through various pharmaceutical processes, which transform these to a convenient dosage form that can be administered and which is assimilable to human body. The most visible concepts of Bhaishajya Kalpana are due to its practical aspect, which not only deals the drug manufacturing but it also includes, the dispensing to the patient in most suitable form.

Through this the drugs are made into an easy palatable form, enhancing the therapeutic properties and nectarising form. Success of the treatment depends on the skillful preparation of the genuine drugs and their application against the diseased condition. Hence the skillful physician stands even superior to those who possess merely a theoretical knowledge of drugs.

The prime objective of pharmaceutical research is to produce a safe, effective and quality drug. Efficacy and safety depend solely on the quality of the drug. The quality of the pharmaceutical product depends not only on the care taken in its preparation, but also in confirming that the genuine raw material have been used and the material has been correctly processed.

Herbal drugs standardization in not new in Ayurveda. In the classics it is mentioned in a codified manner, i.e. Grahya Lakshana, method of collection etc. for raw drug, Siddhi Lakshana of final product are mentioned.

In ancient time, the Ayurvedic drug were prepared by the Physician himself with the help of experienced assistants in the small pharmacy attached to his clinic, so there was no doubt about authentication and quality.

But now a days, increasing demand of Ayurvedic drug resulting large scale manufacturing and wide distribution. Also, most of pharmaceutical industries using substitute drug instead of authentic drugs. Thus, to maintain the good quality, safety and efficacy of Ayurvedic drug,

we must collect the raw material as mentioned in our classics and maintains the uniformity in manufacturing process and final products. Classical text of Ayurveda have mentioned analytical techniques to understand the quality of the end product along with therapeutic properties of finished product.

These are mostly qualitative and subjective. Pharmaceutico - analytical study of both sample of Trayushnadi Gutika[1] and its ingredients were carried out at Nagarjuna Laboratory, Department of Rasashastra and Bhaishajya Kalpana, Government Ayurvedic College, Patna, Bihar.

Aim and Objectives

1. Standardization of Raw Materials - Identifying and verifying the authenticity and purity of ingredients used in Trayushnadi Gutika.
2. Pharmaceutical Processing Evaluation - Assessing the preparation techniques to ensure uniformity in formulation.
3. Physicochemical Analysis of Trayushnadi Gutika prepared by using different Bhavana Dravya

Materials and Methods

Pharmaceutical Study

Procurement of the raw drugs:The crude drugs required for the preparation of the Trayushnadi Gutika were purchased from the local market and were authenticated by the Department of Pharmacognosy of the Institute and Analytical tests were conducted at Arbro Pharmaceuticals Private Limited (Analytical Division), Kirti Nagar, New Delhi (Govt. Approved Test House).

Preparation of Trayushnadi Gutika comprised of following steps:

  • Step No.- 01: Preparation of Yavakuta Churna of Triphala
  • Step No.- 02: Guggulu Shodhana
  • Step No.- 03: Preparation of Trikatu Churna
  • Step No.- 04: Preparation of Triphala Churna
  • Step No.- 05: Preparation of Trayushnadi Gutika sample-A (Bhavana with Gokshur Kwatha)
  • Step No.- 06: Preparation of Trayushnadi Gutika sample-B (Bhavana with Amalaki Swarasa)

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Analytical Study

1. Organoleptic character:

a) Appearance
b) Colour
c) Odour
d) Taste

2. Physico-chemical parameters:

a) Uniformity of weight[2]
b) Disintegration time[3]
c) Loss on drying[4]
d) Determination of pH[5]
e) Determination of Ash value[6]
f) Determination of acid insoluble ash[7]
g) Determination of water soluble extractive[8]
h) Determination of Alcohol soluble extractive[9]
i) Metal Analysis[10]
j) Total Bacterial Count[11]
k) Total Fungal Count[11]

Step No.- 01: Preparation of Yavakuta Churna of Triphala
Reference: Chakradatta.

Name of method: Hammering and Cutting.

Ingredients Required:

1. Haritaki (with seed) - 24.5 kg
2. Bibhitaki (with seed) - 24.5 kg
3. Amalaki (with seed) - 24.5 kg

Apparatus and Utensils: Hammer, Spatula, Weighing machine, Imamdusta, Stainless steel vessels, etc.

Procedure:

  • First of all, all ingredients of Triphala (Haritaki, Bibhitaki and Amalaki) separately received from Depart. of Rasashastra & Bhaishajya Kalpana is cleaned carefully (remove unwanted materials).
  • After the cleaning, the seeds were separated from the all drugs with the help of Hammer.
  • After that all drugs are dried in sun light and then mixed in equal amount (which is minimum in quantity) and thereafter Yavakuta Churna are prepared with the help of Imamdusta.
  • Then Yavakuta Churna was weighed and stored in container.
  • Yavakuta Churna is used for preparation for Triphala Kwatha, which would be used for the Shodhana of Guggulu.

Precautions:

  • Cleaning should be done carefully to minimize the loss happened during cleaning process.
  • All material should be dry properly.
  • Yavakuta preparation of Triphala should be done carefully to minimize the handling loss.

Results: The weight obtained of Triphala Yavakuta Churna after complete processing-

SNName of HerbsWeight of Herbs (with seed)Weight of Herbs (without seed)Weight LossWeight of Herbs used in preparationResidual Amount
1.Haritaki24.5 kg11.500 kg13.00 Kg10.100 kg1.400 kg
2.Bibhitaka24.5 kg10.700 kg13.8 Kg10.100 kg0.600 kg
3.Amalaki24.5 kg10.100 kg14.4 Kg10.100 kg0 kg
Total73.50032.3 Kg41.2kg30.3 Kg29.155 kg

Reason of weight loss:

  • Some loss is due to presence of foreign materials which was eliminated during cleaning process.
  • Maximum losses in herbs were due to seed extraction.
  • Some losses due to handling mistake during Yavakuta Churna preparation.

Step No. 02: Preparation of Triphala Kwatha and Guggulu Shodhana73

Reference: Rasa Jala Nidhi Vol.-III, Chapter-VIII

दुग्धेवात्रिफलाक्वाथेदोलायन्त्रविपाचित: ।
वाससागालितोग्राह्य: सर्वकर्मसुगुग्गुलु: ।। (रस जल निधि Vol.III,Chap.VIII)

Name of method – Dolayantra Vidhi

Materials required:

1. Ashuddha Guggulu - 10 kg
2. Triphala Yavakuta Churna - 20 kg
3.Water - 160 liters

Apparatus and Utensils: Weighing Machine, Imamdusta, Stainless Steel vessel, Spatula, Gas stove marking cloth, thermometer, measuring jar.

Procedure:

  • Triphala Yavakuta Churna Firstly, previously prepared was taken in a stainless-steel vessel which is of 20 kg and then water was added 8 times of total weight of Kwatha Dravyase., 180 liters and mixed it.

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  • After adding water to Triphala Yavakuta Churna, it is left for overnight.
  • Then next day it is kept on gas stove on mild fire to make Triphala Kwatha.
  • When one-fourth of the water content remained (i.e., 40 liters), then fire was stopped and Kwatha was removed from gas stove and was filtered with the help of marking cloth. Now, Triphala Kwatha is ready for Guggulu Shodhana.
  • After that again Triphala Kwatha was taken in wide mouth utensils for Guggulu Shodhana and kept on gas stove on mild fire. Now, Guggulu is placed in a marking cloth and made a Pottali and hang it in utensils with the help of iron rod by the process of Dolayantra-Vidhi.
  • Gradually Guggulu was melted and when completely melted then fire was stopped and Pottali was taken out from the utensils. Now, open the Pottali and remove foreign matter from this.
  • Now again the mixture of Guggulu and Kwatha was kept on gas stove and dried on mild flame till Shuddha Guggulu was obtained.
  • After that thoroughly dried in Sun light and weighed. The final weight of Shodhit Guggulu with Ghana was 6.5 kg.

Observations:

  • Triphala Yavakuta Churna became soft when kept soaked for overnight.
  • During process of Triphala Kwatha Dravya preparations, characteristics smell was observed.
  • Gradually water loss was observed.
  • The colour obtained of prepared Triphala Kwatha was dark brown.
  • During Guggulu Shodhana
  • Process, Kwatha colour becomes start to changing like deep brown in colour and characteristics smell of Guggulu comes out.
  • Gradually Kwatha becomes thick in consistency and sticky.
  • Shuddha Guggulu And lastly thick along with Ghana of Triphala Kwatha was obtained.

Precautions:

  • All procedure done very carefully.

  • Kwatha material should be Yavakuta Churna form only.
  • Always mild fire should be used.
  • Pottali must be dipping in Kwatha materials but not touch the base of utensils.
  • During last stage of preparation of mixture of Guggulu, continuous stirring should be done to avoid sticking of Guggulu in base of utensils.
  • Used utensils should be clean to avoid any contaminations.
  • Marking cloth should be also cleaned which is used for filtration.

Results:

Weight of the Ashuddha Guggulu - 10 kg
Weight of the Shuddha Guggulu - 6.5 kg
Weight loss - 3.5 kg

Cause of weight loss: 

  • Maximum loss is due to presence of foreign materials which was eliminated after complete dissolution of Ashuddha Guggulu.
  • Some loss when Shuddha Guggulu was stored in another container (stick on previous utensils).

Step No. 03: Preparation of Trikatu Churna

Reference: Chakradutta.

Name of method: Cleaning and Grinding.

Materials required:

1. Pippali -1.5 kg
2. Maricha - 1.5 kg
3. Shunthi -1.5 kg

Apparatus and Utensils: Imamdusta, Spatula, Sieve, Stainless steel vessels, Weighing machine, Grinder etc.

Procedure:

  • Firstly collect 1.5 kg of each drug Pippali, Maricha and Shunthi separately in required size of utensils and remove unwanted material/foreign material. Then clean and wash carefully and leave it for drying in sun light.
  • Then all ingredients were mixed and took into Imamdusta for making Churna.
  • Then above Churna placed in Grinder for making fine Churna regarding particle size.

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  • At last prepared Churna was filtered through marking cloth and stored in air-tight container.

Observations:

  • Raw Trikatu having some foreign materials and some defected piece. So, it was removed to obtained good quality product.
  • The raw Trikatu convert into fine powder form.
  • Obtained powder having characteristics smell and colour.

Precautions:

  • The materials should be complete dry. Otherwise very difficult to grind and good quality Churna was obtained. Also loss may be more.
  • The process of grinding should be done very carefully to minimize handling loss.
  • Sieving through marking cloth should be done carefully. So that equal particle size of Churna was obtained.
  • Stored container should be air-tight, clean and dry.

Results:

Total weight of Raw Trikatu - 4.500 kg
Total weight of Trikatu Churna - 3.200 kg
Total loss of Trikatu - 1.300 kg

Reason of weight loss:

  • Most of loss occurred due to presence of foreign particle and defected materials.
  • Some loss during grinding process.
  • Some loss during sieving process because Churna was sieved from marking cloth to obtained equal particle size.

Step No. 04: Preparation of Triphala Churna

Reference: Chakradutta.

Materials required: Triphala Yavakuta Churna - 9.155 kg

Apparatus and Utensils: Imamdusta, Spatula, Sieve, Stainless steel vessels, Weighing machine, Grinder, Marking cloth, etc.

Procedure:

  • Firstly previously prepared Triphala Yavakuta Churna was taken in a stainless steel vessel which is of 9.155 kg to made coarse powder.
  • Then all ingredients took into Imamdusta for making Churna.
  • Then above Churna placed in Grinder for making fine Churna regarding particle size.
  • At last prepared Churna was filtered through marking cloth and procured fine Churna after Sieving.
  • And stored in air-tight container.

Observations:

  • The Yavakuta Churna converts into fine powder form.
  • Obtained powder having characteristics smell and dark brown in colour.

Precautions:

  • The materials should be complete dry. Otherwise very difficult to grind and good quality Churna was obtained. Also, loss may be more.
  • The process of grinding should be done very carefully to minimize handling loss. Sieving through marking cloth should be done carefully. So that equal particle size of Churna was obtained.
  • Stored container should be air-tight, clean and dry.

Results:

  • Total weight of Triphala Yavakuta Churna - 9.155 kg
  • Total weight of Triphala Churna - 6.300 kg
  • Total weight loss of Triphala Yavakuta Churna - 2.855 kg

Reason of weight loss:

  • First loss occurred during process of drying of Yavakuta Churna form because it was taken from Step No.-1.
  • Some loss during grinding process.
  • More loss during sieving process because Churna was sieved from marking cloth to obtained equal particle size.

Step No. 05: Preparation of Trayushnadi Gutika sample-A (Bhavana with Gokshur Kwatha)

Reference: Chakradatta Pramehadhikar

Name of method: Guggulu Kalpana


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Materials required:

A. All materials are taken from previous practical

1. Trikatu Churna - 1.425 kg
2. Triphala Churna - 1.425 kg
3. Shuddha Guggulu - 2.850 kg
4. Gokshur (for Kwatha preparation) - 2.5 kg

B. Water as per requirement.

Apparatus and Utensils: Mortar and Pestle, Spatula, Sieve, Stainless steel vessels, Gas stove, Marking cloth, etc.

Procedure: The whole procedure could be divided into two steps-

Phase 1: Preparation of Gokshur Kwatha

Procedure:

  • Firstly, whole Gokshur was taken in a stainless steel vessel which is of 2.5 kg and then separate foreign materials and placed in Imamdusta for Yavakuta Churna
  • After that water was added 8 times of total weight of Kwatha Dravyase., 20 liters and mixed it.
  • After adding water in Gokshur, it was left overnight.
  • Then next day it was kept on gas stove on mild heat to make Gokshur Kwatha.
  • When one-fourth of the water content remained (i.e., 4 Liters), then heat was stopped and utensils was removed from gas stove and filtered with the help of marking cloth. Now, Gokshur Kwatha is ready for preparation of Trayushnadi Gutika sample A.

Observations:

  • Raw Gokshur was converted into Yavakuta Churna
  • During process of Gokshur Kwatha Dravya preparations, characteristics smell was observed.
  • Gradually water loss was observed.

Precautions:

  • All procedure done very carefully.
  • Kwatha material should be Yavakuta Churna form only.

  • Always mild to medium heat should be preferred.
  • Used utensils should be clean to avoid any contaminations.
  • Marking cloth should be also cleaned which is used for filtration.

Phase 2: Preparation of Trayushnadi Gutika (sample A)

Procedure:

  • Prepared Kwatha of Gokshur (some amount) was taken in wide mouth utensils which were taken from step 1, again kept on gas stove on mild heat.
  • Then added Shuddha Guggulu in this Kwatha and stirred continuously.
  • After sometimes Guggulu start to become melting and Kwatha mixture started to become viscous.
  • When mixture obtained Lehya like consistency then stop to heat and rest for cooling.
  • After that equal amount of Trikatu and Triphala Churna was added with respect to Shuddha Guggulu and remains Gokshur Kwatha was taken as a Bhavana and mixed properly. After that this mixture was put in Sun light for further drying.
  • Dry material was kept in Mortar and well triturate the material with the help of Pestle and made Gutikae. Trayushnadi Gutika sample A.
  • Again, Gutika was placed in Sun light for complete drying.
  • After complete drying total Gutika was weighed and stored in air-tight container.

Observations:

  • The colour of end product was Blackish.
  • Characteristics smell was obtained.

Precautions:

  • Shuddha Guggulu was completely melted in Kwatha Dravyas and stirred continuously otherwise stick to the utensils.
  • When added main ingredients then material should not be hot otherwise chances to burn.
  • Prepared material should be complete dry otherwise there is chances to fungal growth.

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  • Prepared Gutika should be stored in air-tight container when dry properly.

Results:

  • Weight of total material of Trayushnadi Gutika sample A - 5.700 kg
  • Weight of final prepared material of Trayushnadi Gutika sample A - 5.675 kg.
  • Weight of final prepared material of Trayushnadi Gutika sample A - 5.425 kg
  • For testing and sampling - 250 gm

Step No. 06: Preparation of Trayushnadi Gutika sample-B (Bhavana with Amalaki Swarasa)
Reference: Chakradatta Pramehadhikara

Name of method: Guggulu Kalpana

Materials required:

A. All materials are taken from previous practical:

1. Trikatu Churna - 1.425 kg
2. Triphala Churna - 1.425 kg
3. Shuddha Guggulu - 2.850 kg
4. Amalaki Swarasa obtained (for Kwatha preparation) - 2.4 liter

B. Water as per requirement:

Apparatus and Utensils: Mortar and Pestle, Spatula, Sieve, Stainless steel vessels, Gas stove, Marking cloth, weighing machine, etc.

Procedure: Process could be divided into two steps

Phase 1: Preparation of Amalaki Swarasa

Procedure:  

  • Firstly, wet Amla of 10 kg for Amalaki Swarasa preparations was taken in large utensils and then wash from water.
  • After that all Amla was cut into small pieces and seeds was separate out and then kept in Mortar and Pestle for prepare Kalka like paste.
  • Then paste was put in Marking cloth and squeeze hardly to obtained Swarasa. Total 2.4 litre Amalaki Swarasa was obtained.

Observations:

  • Wet Amla was bright green in colour but after trituration it becomes faded green paste form obtained.

  • Characteristics sharp smell was found.

Precautions:

  • Always taken fresh Amla and large size.
  • Paste made properly and squeezed to obtain proper amount of Swarasa for Trayushnadi Gutika sample B preparation.

Phase 2: Preparation of Trayushnadi Gutika (sample B)

Procedure:  

  • Prepared Shuddha Guggulu and some water was kept on mild heat and stirred continuously.
  • After sometimes Guggulu start to become melting and started to become viscous.
  • When Guggulu was completely melted and obtained Lehya like consistency then stop to heat and rest for cooling.
  • After that equal amount of Trikatu and Triphala Churna was added with respect to Shuddha Guggulu and Amalaki Swarasa was taken as a Bhavana and mixed properly. After that this mixture was put in Sun light for further drying.
  • Dry material was kept in Mortar and well triturate the material with the help of Pestle and made Gutikae., Trayushnadi Gutika sample B.
  • Again, Gutika was placed in Sun light for complete drying.
  • After complete drying total Gutika was weighed and stored in air-tight container.

Observations:

  • The colour of end product was bright Blackish.
  • Characteristics smell was obtained.

Precautions:

  • Shuddha Guggulu was completely melted in Dravyas and stirred continuously otherwise stick to the utensils.
  • When added main ingredients then material should not be hot otherwise chances to burn.
  • Prepared material should be complete dry otherwise there is chances to fungal growth.
  • Prepared Gutika should be stored in air-tight container when dry properly.

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Results:

  • Weight of total material of Trayushnadi Gutika sample B - 5.700 kg.
  • Weight of prepared material of Trayushnadi Gutika sample B - 5.575 kg.
  • Weight of final prepared material of Trayushnadi Gutika sample B - 5.375 kg
  • For testing - 200 gm.

Preparation of Triphala Yavakuta Churna & Triphala Churna

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Figure 1: Haritaki

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Figure 2: Bibhitaki

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Figure 3: Amalaki

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Figure 4: Ashuddha Guggulu

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Figure 5: Prepared Triphala Churna

Guggulu Shodhana

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Figure 6: Preparation of Triphala Kwatha

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Figure 7: Prepared Triphala Kwatha


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Figure 8: Pottali hanging in Triphala Kwatha

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Figure 9: Guggulu after filtration

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Figure 10: Filtered Guggulu on heat

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Figure 11: Shuddha Guggulu

Preparation of Trikatu Churna

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Figure 12: Pippali

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Figure 13: Maricha

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Figure 14: Shunthi

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Figure 15: Prepared Trikatu Churna


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Preparation of Trayushnadi Gutika sample-A (Bhavana with Gokshur Kwath)

Step: 01

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Figure 16: Gokshura

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Figure 17: Prepared Gokshura Kwatha

Step: 02

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Figure 18: Trikatu Churna

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Figure 19: Triphala Churna

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Figure 20: Shuddha Guggulu

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Figure 21: Final stage of Trayushnadi Gutika

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Figure 22: Final stage of Trayushnadi Gutika

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Figure 23: Trayushnadi Gutika


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Observations and Results

Table 1: Organoleptic characters

SNTestResult
1.   AppearanceRound Vati
2.ColourKrishna varna
3.OdourGuggulu Gandhi
4.TasteKatu

Table 2: Results of Physico-chemical Study

SNParametersValue (in g) (Trayushnadi Gutika S-A)Value (in g) (Trayushnadi Gutika S-B)
1.Wt. of 20 Vati (Tablets)20.58 g20.56 g
2.Average weight1.029 g1.028 g
3.Highest weight1.21 g1.13 g
4.Lowest weight0.945 g0.980 g
5.Disintegration time (in NS)38 min35 min
6.Disintegration time (in N/10 HCl)29 min25 min

Table 3: Comparative analytical data of the Trayushnadi Gutika (Sample - A & B).

SNAnalytical ParameterUnitsResults (TG S-A)Results (TG S-B)Test Method ReferenceLimits as per ASU PharmacopoeiaConformity
1.pH (1% aqueous solution)-3.783.61API--
2.Loss on drying at 105°Cg/100g% w/w10.2112.62API--
3.Total Ash% w/w5.016.12API--
4.Acid-insoluble Ash% w/w0.320.19API--
5.Water-soluble extractive% w/w25.3232.29API--
6.Alcohol-soluble extract% w/w13.7851.93API--
7.Metal analysis:
a. Lead (as Pb)		mg/kg1.882.31APL/CHE/STP-112-YES
b. Arsenic (as As)mg/kg1.132.88
c. Cadmium (as Cd)-Below quantification limitBelow quantification limit
d. Mercury (as Hg)mg/kg0.6720.889
8.Total bacterial count (aerobic microbial)cfu/gm315280APINot more than 105YES
9.Total fungal count (yeast & mould)cfu/gm13590APINot more than 103YES

Discussion

In the analytical parameters, both sample of Trayushnadi Gutika was found Round Vati in appearance, Krishna in colour, Guggulu - Gandhi in odour and katu in taste. In Trayushnadi Gutika (sample A & B), average weights of both Vati are - 1.029gm, 1.028 gm, respectively. Its disintegration time in Normal solution (NS) is - 38-minute, 35 minute and disintegration time in N/10 HCl is - 29-minute, 25 minutes respectively.

Discussion on physico-chemical results:

The data presented in Table no. 3 reveals that the pH (1% aqueous solution is comparatively slightly high in Gokshur Kwath Bhavit Trayushnadi (3.78) as compared to Amalaki Swaras Bhavit Trayushnadi Gutika (3.61).

The LOD at 105°C is comparatively high in Amalaki Swaras Bhavit Trayushnadi Gutika (12.61%) as compared to Gokshur Kwath Bhavit Trayushnadi Gutika (10.21%).

The ash value is comparatively high in Amalaki Swaras Bhavit Trayushnadi Gutika (6.12%) as compared to Gokshur Kwath Bhavit Trayushnadi Gutika (5.01%).

The acid-insoluble ash value is comparatively high in Gokshur Kwath Bhavit Trayushnadi Gutika (0.32%) as compare to Amalaki Swaras Bhavit Trayushnadi Gutika (0.19%).

The Water-soluble extractive value is comparatively high in Amalaki Swaras Bhavit Trayushnadi Gutika (32.29%) as compared to Gokshur Kwath Bhavit Trayushnadi Gutika (25.32%).


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The Alcohol-soluble extractive value is comparatively high in Amalaki Swaras Bhavit Trayushnadi Gutika (51.93%) as compared to Gokshur Kwath Bhavit Trayushnadi Gutika (13.78%).

Metal analysis (respectively Pb, As, Cd, Hg) are comparatively high in Amalaki Swaras Bhavit Trayushnadi Gutika (2.31, 2.88, below limit and 0.889 mg/kg) as compared to Gokshur Kwath Bhavit Trayushnadi Gutika (1.88, 1.13, below limit and 0.672 mg/kg) but both samples are within the limit as per ASU Pharmacopoeia.

Total aerobic microbial count and total yeast & mould count value are comparatively high in Gokshur Kwath Bhavit Trayushnadi Gutika (315 & 135 cfu/g respectively) as compare to Amalaki Swaras Bhavit Trayushnadi Gutika (280 & 90 cfu/g respectively) but both are in within limit as par API. Overall Gokshur Kwath Bhavit Trayushnadi Gutika having better physico-chemical result than Amalaki Swaras Bhavit Trayushnadi Gutika except total aerobic microbial count and total yeast & mould count.

Conclusion

Trayushnadi Gutika sample A and B was prepared according to Chakradatta Pramehadhikara. The ingredients of both drugs were similar except Bhavana. Trayushnadi Gutika sample A having Bhavana of Gokshur Kwath and Trayushnadi Gutika sample B having Bhavana of Amalaki Swaras. The comparative analytical evaluation of Trayushnadi Gutika (Sample A and Sample B) indicates that both formulations adhere to standard physico-chemical parameters, with notable differences influenced by the Bhavana process. Sample A, prepared with Gokshur Kwath Bhavana, exhibited a slightly higher pH, lower loss on drying, and greater acid-insoluble ash value compared to Sample B, which was processed with Amalaki Swaras Bhavana. Additionally, the extractive values - both water-soluble and alcohol-soluble - were found to be higher in Sample B, suggesting a greater solubility profile in both mediums.

Metal analysis confirmed that both samples were within the permissible limits prescribed by the ASU Pharmacopoeia, while microbial limits also remained within the acceptable range per API standards, despite slightly elevated values in Sample A.

In summary, the study highlights that while both variants of Trayushnadi Gutika maintain pharmaceutical integrity, Gokshur Kwath Bhavit Trayushnadi Gutika demonstrated a relatively favorable physico-chemical profile except in microbial counts. These findings suggest that the Bhavana process plays a significant role in shaping the formulation's characteristics, potentially influencing its therapeutic applications. Further investigation into clinical efficacy and pharmacological impacts may provide deeper insights into their comparative benefits.

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