Vadodara, Gujarat. fssai (Food Safety and Standards Authority of India) standard Tila Taila, Go-ghrita and Go-dugdha were procured.

Preparation of Dadrughni Vati (Lepa) and Dadrughna Malahara: All the batches of Dadrughni Vati (Lepa) were prepared as per the reference of Bheshaj Samhita^[2] and Dadrughna Malahara was a modified dosage form of Dadrughni Vati (Lepa) prepared in the Pharmaceutical Laboratory of Upgraded Department of Rasashastra and Bhaishajya Kalpana, Government Ayurved College, Vadodara, Gujarat.

Place of Analytical study: Quality Testing Laboratory of the Upgraded Department of Rasashastra and Bhaishajya Kalpana, Government Ayurved College, Vadodara, Gujarat and Vasu Research Centre, Division of Vasu Healthcare PVT. LTD. Vadodara, Gujarat.

Organoleptic characters: The Organoleptic characters i.e., colour, appearance, odour, taste and texture of the samples were observed by sensory observations. The samples were carried out to confirm the identification of raw material as well as finished products by organoleptic characters.

Physico-chemical parameters: Physicochemical parameters were analyzed according to the Ayurvedic pharmacopeia of India (API).

Preliminary analysis carried out were pH value,^[3] loss on drying,^[4] water soluble extractive,^[5] alcohol soluble extractive,^[6] total ash,^[7] acid insoluble ash,^[8] viscosity,^[9] specific gravity,^[10] acid value,^[11]saponification value,^[12] refractive index,^[13] iodine value,^[14]Total Solid Content,^[15] Uniformity of weight,^[16] Hardness Test^[17] and Spreadability Test^[18]

Observations and Results

Organoleptic characters:The organoleptic characters of all raw materials of Dadrughni Vati (Lepa) (DL) and Dadrughna Malahara (DM) are mentioned in table no. 1.

Physicochemical analysis:Physicochemical analysis of Ashuddha and Shuddha Tankana is shown in table no. 2

Table 4: Physicochemical analysis of Ashuddha and Shuddha Gandhaka

Physicochemical analysis of Chakramarda Beeja Churna is shown in table no. 5.

Table 5: Physicochemical analysis of Chakramarda Beeja Churna

Physicochemical analysis of Sarjarasa Churna shown in table no. 6

Table 6: Physicochemical analysis of Sarjarasa Churna

Table 7: Showing the Physicochemical analysis of Tila Taila

Table 8: Showing the Physicochemical analysis of Jambiri Nimbu Svarasa

Discussion

pH indicates the acidity or alkalinity of a solution. A suitable pH range is important for preserving the active compounds and ensuring optimal solubility and absorption.^[19] The data reveals that pH values of AT, ST, AS, SS, AG, SG, CB andS were 10.9, 10.3, 2.36, 2.54, 9.13, 6.04, 4.70 and 4.51 respectively.

The decreased pH value of Shodhita Tankana in comparison to Ashodhita Tankana is the hydrous form of borax promotes higher pH levels due to better solvation and ionization of borate ions in the presence of water, whereas the anhydrous form, lacking water, leads to less effective ionization and a lower pH.^[20]

The degree to which a compound dissociates into its constituent ions when dissolved in water significantly affects the concentration of hydrogen ions (H⁺) in thesolution; more complete dissociation leads to the release of more H⁺ ions, resulting in a lower pH and a more acidic solution. In the case of potash alum, the anhydrous form may interact with water differently, potentially resulting in a lower degree of H⁺ release compared to the hydrous form. This difference in interaction can produce a higher pH in the anhydrous form, indicating a less acidic solution overall.^[21]

The pH of Gandhaka (sulfur) can vary based on its form and purity. In Ashuddha Gandhaka may have a more variable pH, due to the presence of impurities or contaminants. Ashuddha Gandhaka may contain physical impurities such as foreign particles (e.g., sand and stones) as well as chemical impurities like Inorganic form arsenate or arsenite and other substances.^[22] These salts can yield a pH that is typically around neutral to slightly alkaline (approximately 7 to 9). ThepH of Shuddha Gandhaka istypically neutral to slightly acidic, generally around 6 to 7, depending on the specific purification method and any residual impurities.^[23]

The pH values of both CB and S are not given in API. However, they comply with the findings from prior research work.^[24,25]

Loss on drying value of AT, ST, AS, SS, AG, SG, CB andS were 27.62%, 7.61%, 35.18%, 1.94%, 0.5%, 0.82%, 7.81% and 2.80% respectively indicating that the powder has an appropriate moisture content, ensuring stability and preventing microbial growth.^[26]

Borax commonly exists as borax decahydrate (Na₂B₄O₇·10H₂O), where the water molecules are released during combustion, resulting in a lower concentration of borate ions in the ash. In contrast, the anhydrous form contains less water, leading to a higher concentration of borate ions and a higher Ash value.^[33] Similarly, potash alum is often found as potassium aluminum sulfate dodecahydrate (Kal (SO₄)2·12H₂O), and the water in its hydrous form dilutes the metal ion concentration, contributing to a lower Ash value compared to the anhydrous form, which retains a higher concentration of inorganic material after combustion.^[34]

The total Ash Value in AG and SG does not differ and aligns closely with previous research work.^[35]

The total Ash value of CB complies with the API standard and theash value of S complies with previous work. Both values are closely similar to those indicating that both drugs are genuine. This parameter indicates the presence of non-soluble minerals, such as silicates or other impurities, that may come from soil or contamination.^[36]

The human metabolic process and pharmacokinetics depend upon the purity and human-acceptable forms of the drug. When the AT, ST, AS, SS, AG, SG, CB andS were treated with hydrochloric acid, 9.60 %, 4.45 %, 3.62 %, 4.010 %, 1 %, 1.03 %, 0.26 % and 3.22 % respectively, acid-insoluble ash was detected, which signifies the genuineness of the product and suggests it is best in terms of solubility and absorption. As the acid insoluble ash value of AT and ST is within thepermissible limits, samples are not contaminated, showing thegenuineness of thedrug. The acid insoluble ash value in AG and SG does not differ and aligns closely with previous research work.^[37]

The total acid insoluble ash value of CB meets the API standard, while the acid insoluble ash value of S aligns with prior studies. Both values are quite similar, suggesting that both substances are authentic.

The data reveals that water-soluble extractive values of AT, ST, AS, SS, AG, SG, CB andS were 92.97 %, 99.07 %, 97.70 %, 99.10 %, 0.079 %, 0.23 %, 31.13 % and 1.90 % respectively. This value reflects the presence of water-soluble compounds, such as sugars, amino acids, vitamins, and certain active phytochemicals.^[38]

The average ash value of DL was 19.58%, reflecting its inorganic content from both herbs and minerals. This value aligns with the expected ash values of the formulation's ingredients, suggesting no significant adulteration by substances like sand or soil. Additionally, the average acid insoluble ash (AIA) value was 5.70%, indicating high bioavailability; AIA can hinder skin absorption and reduce the efficacy of active ingredients.^[45]

The average water-soluble extractive value was 44.12%, compared to 13.97% for alcohol-soluble extractives. The higher water-soluble extractives enhance the bioavailability of hydrophilic active ingredients, making the formulation milder and suitable for a broader range of users. These components also improve moisturizing properties,^[46] aiding skin hydration, and making DL beneficial for conditions like Dadru with symptoms of Kandu and Rukshta. The average hardness of DL was 9.8, and the average weight was 3651 mg (3.65 g), both uniform across all batches. Tablet hardness is essential for mechanical strength, manufacturing quality, patient compliance, and overall stability. All Vati was consistent in weight. The average specific gravity of DM was 0.930, consistent across all batches, influencing the spreadability and absorption of the formulation lower specific gravity allows for easier spreading and faster absorption.^[47] The average acid value was 2.22, indicating a minimal level of free fatty acids, suggesting the formulation is milder and suitable for sensitive skin. This low acid value also correlates with better stability, as higher values can indicate degradation while maintaining effective emollient properties for improved skin feel and moisture retention.^[48]

The average saponification value of DM was 118.57, indicating a significant presence of short- and medium-chain fatty acids. This suggests good emulsifying properties, enhancing ointment stability, and contributing to smoother texture and better spreadability, facilitating improved absorption of active ingredients.^[49]

The average iodine value was 77.11, indicating some unsaturation and making the formulation less prone to oxidation and rancidity, thus enhancing stability and shelf life.^[50] Iodine, acid, and saponification values serve as indicators of rancidity related to free fatty acid liberation. The average viscosity of DM was 15,64,333 cp, and the average spreadability was 657.95, both consistent across all batches.