|
 
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| ORIGINAL ARTICLE |
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| Year : 2023 | Volume
: 8
| Issue : 3 | Page : 230-241 |
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Pharmaceutical standardization and analytical validation of Sanjivani Vati
Shreshtha Kaushik, Pramod Yadav, Pradeep Kumar Prajapati
Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi, Delhi, India
| Date of Submission | 29-May-2022 |
| Date of Acceptance | 15-Feb-2023 |
| Date of Web Publication | 16-Aug-2023 |
Correspondence Address:
Dr. Shreshtha Kaushik
Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi 110076, New Delhi
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jdras.jdras_77_22
BACKGROUND: Standardization and validation for Ayurvedic polyherbal preparation using modern techniques of analysis are extremely important. Sanjivani Vati (SV) is one such a multicomponent formulation, which is well known for its multiple uses. Even so, it lacks the latest scientific measures to ensure its safety and efficacy more precisely. So, an attempt has been made to standardize the pharmaceutical procedure of SV and to validate its analytical profile. To develop Standard Manufacturing Procedure (SMP) of SV and to validate its quality control parameters. METHODS: Five batches of SV were prepared in the pharmaceutical laboratory, All India Institute of Ayurveda, New Delhi, India, following a classical reference. They were further subjected to an organoleptic, relevant physicochemical and physical, heavy metal, and microbial limit analysis along with a chromatographic as well as spectroscopic evaluation, that is, Fourier transform infrared spectroscopy (FTIR) and gas chromatography-mass spectrum (GCMS). RESULTS: A batch size of 100 g of SV can be prepared by using 10 g of its each ingredient, 250 mL of cow’s urine required for levigation of 6 h 45 min with a yield of around 730 pills of average weight 130.64 ± 2.43 mg, and after drying for 5 h 52 min at 50°C. These findings accomplished the chief objective of its pharmaceutical standardization. Analytical specifications of SV are highly amorphous powder, mild bitter in taste with odor of cow’s urine and having brownish black color. All the physicochemical parameters were found validated as per official standards except total ash value. Moreover, FTIR showed the presence of hydroxy, alkane, amide, acyl, alkoxy, and aromatic compounds. Fingerprinting assay revealed seven and nine retardation factor values at 254 and 366 nm, respectively. Furthermore, a total of 21 compounds were detected in GCMS. Pills were also observed free from specific heavy metals, microbes, and pesticides indicating good manufacturing practices. CONCLUSION: This is a preliminary report generating results for standardization as well as validation of SV that could be used for future references. Moreover, further works should be carried out to explore the therapeutic outcomes of this medication. Keywords: Polyherbal, quality control, Sanjivani Vati, standardization, validation
How to cite this article:
Kaushik S, Yadav P, Prajapati PK. Pharmaceutical standardization and analytical validation of Sanjivani Vati. J Drug Res Ayurvedic Sci 2023;8:230-41 |
How to cite this URL:
Kaushik S, Yadav P, Prajapati PK. Pharmaceutical standardization and analytical validation of Sanjivani Vati. J Drug Res Ayurvedic Sci [serial online] 2023 [cited 2023 Sep 23];8:230-41. Available from: http://www.jdrasccras.com/text.asp?2023/8/3/230/383702 |
| Introduction | |  |
Standardization can be defined as the procedure toward creating and concurring upon applied standards. World Health Organization (WHO) emphasizes on the importance of the qualitative and quantitative methods for characterizing, quantification, and the fingerprint profiles of the samples. The herbal raw material is prone to a lot of variations due to several factors, the important ones being the identification of the plants and seasonal variations (at the time of collection), the ecotypic, genotypic, and chemotypic variations, drying and storage conditions. etc.[1] Standardization is achieved through minimizing the inherent variation of natural product composition through quality assurance practices applied to agricultural and manufacturing processes.[2] Indian system of medicine advocated the utilization of multicomponent formulations for preserving health as well as curing ailments in a comprehensive manner. Owing to extensive variations shown by different pharmaceutical firms within the same Ayurvedic product, questions pertaining to quality and efficacy of drug arise. In consequence, the need of the moment is to develop standardization protocols as well as to validate them to have uniformity, reliability, and authenticity of formulations at global levels.
Sanjivani Vati (SV) is a widely known therapeutic pill described in Ayurvedic Formulary of India.[3] It comprises equal parts of 10 herbs [Table 1]. Besides, Gomutra (Cow’s urine) is also one of the constituents of prime importance, used for Bhavana (Impregnation). Ancient seers have recommended preparing it with the strength of one Gunja (125 mg) and administering orally along with Aardraka Swarasa (extracted juice of rhizome of Zingiber officinale Roscoe) or warm water as adjuvant. The dosage of SV varies depending upon different diseases such as one pill for Ajirna (indigestion) and Gulma (abdominal lump), two pills for Visuchika (gastroenteritis with piercing pain), three pills for Sarpadamsa (snakebite), and four pills for Sannipaatika Jwara (Disease which causes anguish to mind and body). Though data on quality control standards for SV have been described in Ayurvedic Pharmacopoeia of India,[4] it is the desideratum of time to validate the available parameters as well as to include more scientific tools to make the quality standards more applicable and meaningful. On account of this, the present study has been endeavored to standardize pharmaceutical procedure of SV and to validate its analytical profile using esoteric and suitable analytical techniques such as physicochemical and physical tests, CHN-O analysis, heavy metal analysis through inductive coupled plasma with atomic emission spectrophotometer (ICP-AES), Fourier transform infrared spectroscopy (FTIR), microbial limit test, high-performance thin-layer chromatographic (HPTLC), and gas chromatography-mass spectrum (GCMS) analysis.
| Materials and Methods | | |
Procurements of raw material
All requisite crude drugs except Vatsanabha were procured from a local herbal drugs supplier of Khari Baoli Market, Delhi, in dried form. Vatsanabha was purchased from a local vendor, Jaipur. Fresh Gomutra (Cow’s urine) was collected from nearby cowsheds in the early morning.
Authentication of raw material
The procured samples of individual raw botanicals were authenticated by Raw Materials Herbarium and Museum, Delhi, under CSIR—National Institute of Science Communication and Policy Research. The authentication numbers for its constituents issued by the institute are as follows: Vidanga (4081-82-2), Nagara (4081-82-8), Krishna (4081-82-9), Pathya (4081-82-6), Amala (4081-82-5), Bibhitaki (4081-82-4), Vacha (4081-82-3), Guduchi (4081-82-7), Bhallataka (4081-82-1) and Vatsanabha (4082-83-1).
Preparation of Sanjivani Vati
This pharmaceutical study was carried out at the Departmental Laboratory of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi, India. The formulation composition of SV has been given in [Table 1]. The entire procedure was accomplished in three phases:
- Processing (Shodhana)
- Powdering (Churnikarana)
- Preparation of pills (Vati nirmana)
Processing (Shodhana)
Classical Ayurveda treatises have prescribed specific Shodhana (processing) techniques exclusively for Schedule E (1) drugs as per Drug and Cosmetic Act, which aid in making these drugs harmless and render them acceptable for therapeutic intervention. SV possesses a couple of poisonous drugs from vegetable origin: Bhallataka and Vatsanabha. Therefore, Shodhana of both drugs was done following meticulous classical guidelines. The fruits of Bhallataka (BF), which submerged in water during Prashasta-Aprashasta Pariksha (Examination for quality drugs),[5],[6] were selected for Shodhana, whereas the floating fruits were discarded. Bhallataka Shodhana was carried out by rubbing in Ishtika Churna (Brick powder).[7] Besides, Vatsanabha Shodhana was done in Gomutra by the principle of Nimajjana (Dipping) and Atapashoshana (Soaking in sunlight) for three days.[8] On the first day of shodhana, ashuddhaVatsanabha tubers were spread into a Stainless Steel tray. Then, required quantity of Gomutra was poured into that tray and was placed under the sunlight. Next day, the tubers were collected and cut into small pieces with the help of cutter. These tuber pieces were again spread in the tray and fresh Gomutra was poured into the tray and kept under sun light. The process was also repeated on next day. On 4 th day, the outer covering of all the pieces was removed with the help of scalpel blade. They were further washed with hot water to remove odour of Gomutra. Then, they were allowed to dry completely in shade. The details pertaining to Bhallataka Shodhana and Vatsanabha Shodhana have been depicted in [Table 2] and [Table 3] and [Figures 1]A–H and [Figure 2]A–H. Moreover, the changes observed in Gomutra have also been given in [Table 4].  | Figure 1: Steps involved in Shodhana of Bhallataka. (A) Ashuddha (Raw) Bhallataka. (B) Examination of Prashasta-Aprashasta Bhallataka. (C) Prashasta Bhallataka. (D) Decapping of Bhallataka. (E) Decapped Bhallataka. (F) Embedding of Bhallataka in Ishtika churna for 3 days. (G) Washing with hot water. (H) Drying of Shuddha Bhallataka
Click here to view |
 | Figure 2: Steps involved in Shodhana of Vatsanabha. (A) Ashuddha (Raw) Vatsanabha. (B) Gomutra (Cow’s urine). (C) Soaking of Ashuddha Vatsanabha in Gomutra under sunlight. (D) Cutting of Vatsanabha into small pieces. (E) Soaking of small pieces of Vatsanabha in Gomutra again. (F) Removal of outer covering of Vatsanabha with scalpel. (G) Washing of Vatsanabha with hot water. (H) Drying of Shuddha Vatsanabha
Click here to view |
Powdering (Churnikarana)
The other eight ingredients [S. No. 1–8 in [Table 5]] were crushed in mortar and pestle individually, grinded in mixer grinder, and passed through sieve # 85 to prepare their fine powder.
The collated outlook of each powder has been depicted in [Table 5].
Preparation of pills (Vati nirmana)
Initially, both Shuddha Vatsanabha and Shuddha Bhallataka in mentioned quantity were soaked in Gomutra in stony Khalva yantra (mortor) for 3 h [Figure 3]I. Then, it was triturated for 1 h to form paste [Figure 3]J. The powders of other eight ingredients [[Figure 3]A–H] were collected in equal proportions into a clean stainless-steel vessel. Mixing was done manually in a uniform direction with a clean, dry spatula until the formation of a homogenous blend. Later, this blend was added to that paste followed by single Bhavana (levigation) with Gomutra. The amount of Bhavana Dravya (Gomutra) sufficient to convert the whole mass into muddy consistency (Rasa-pankavata) was assumed to be sufficient. Levigation was done until Subhavita Lakshana (attainment of proper consistency of the levigated mass so that pills can be rolled [[Figure 3]K] was observed. Then, pills [Figure 3]J were rolled manually and dried in a digital oven. After complete drying, the pills were stored in airtight glass jars. In similar way, a total of 5 batches of 100 g of SV were prepared. Around 730 pills of approximately 125 mg were rolled manually in each batch. The results for five batches along with their average have been depicted in [Table 6]. Average values are the mean of five independent repeated experiments and expressed as mean ± standard deviation (SD). | Figure 3: Pharmaceutical processing of Sanjivani Vati. (A) Vidanga Churna. (B) Shunthi Churna. (C) Pippali Churna. (D) Haritaki Churna. (E) Amalaki Churna. (F) Bibhitaki Churna. (G) Vacha Churna. (H) Guduchi Churna. (I) Soaking of Vatsanabha and Bhallataka in Gomutra. (J) Paste of Vatsanabha and Bhallataka. (K) Levigated mass after adding all other ingredients. (L) Prepared pills of Sanjivani Vati after drying
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Thereafter, organoleptic parameters viz. Sparsha (consistency), Rupa (color), Rasa (taste), and Gandha (odor); applicable physicochemical evaluation including determination of loss on drying,[9] total ash value,[10] acid insoluble ash,[11] water soluble ash,[12] water soluble extractive,[13] alcohol soluble extractive,[14] and pH[15] were carried out for each batch of SV by complying to standard guidelines laid down in the respective sections of Ayurvedic Pharmacopoeia of India. In addition, physical tests of Vati such as size, hardness,[16] friability,[17] uniformity of weight,[18] were also performed in accordance with the standard procedures. Moreover, Sophisticated Instrumental Analyses such as high-performance thin-layer chromatography, CHN-O analysis, FTIR, GCMS, heavy metal estimation through ICP-AES, and total microbial load were also carried out.
High-performance thin-layer chromatography
Preparation of test sample
A total of 2-g powder of SV was accurately weighed in a conical flask and 20 mL of methanol was added to it. Then, it was refluxed for 15 min on water bath and filtered through Whatman filter paper no. 1. Afterwards, the filtrate was taken in an evaporating dish and evaporated to dryness. Then, the sample was reconstituted with 10 mL of methanol. The test solution, thus, obtained was subjected to chromatographic analysis.
Preparation of spray reagent
A total of 0.5-mL anisaldehyde is mixed with 10-mL glacial acetic acid, followed by 85-mL methanol and 5-mL sulfuric acid (98%).
Instrumentation and chromatographic conditions
CAMAG Linomat 5 was used for band application on aluminum sheets precoated with silica gel 60 F254 (Merck). The plates were developed up to 80 mm with a solvent system—toluene:ethyl acetate:formic acid, 10:3:1 v/v in CAMAG glass twin-trough chamber previously saturated with mobile phase vapor for 30 min at 25°C. The densitometric scanning was performed at absorbance 254 and 366 nm after derivatization with anisaldehyde sulfuric acid reagent in CAMAG dip tank for about 1 min and drying at TLC Plate Heater at 100°C ± 5°C for 3 min. Spots were well resolved in the chromatogram of sample. The Rf values [Figure 4] were recorded, and photographs were taken.
| Results and Discussion | | |
About 27.30% of total weight loss has been observed in Bhallataka Shodhana. It was found almost similar (27.44%) to a previous study.[19] This loss was due to decapping of Bhallataka and reduction of their oil content. Approx. 20.60% and 5.63% of weight loss were found after cutting thalamus and placing fruits in brick powder for 3 days, respectively. The process of dipping in brick powder leads to the absorption of oil as well as loss of volatile constituents. Thus, it can also be interpreted as loss of oil contents, which was found to be around 5.63%. Other studies reported total weight loss of 22.08%[20] and 42.50%[21] in Bhallataka shodhana. It is due to adopting a different method of Shodhana. Research studies reported that raw Semecarpus anacardium fruit contains 90% anacardic acid and 10% anacardol. In shodhana, this anacardic acid gets converted into less toxic anacardol due to decarboxylation of the oil. Decarboxylation process may start right from cutting the fruit itself and will be catalyzed by giving heat treatment.[22] Thus, the percentage of anacardol in Bhallataka has been reported to be increased after shodhana.[23]
Almost 40% loss has been observed in Shodhana of Vatsnabha. It complies with the previous work done, which reported that 39.2% and 33.34% loss were observed in Shodhana of A. chasmanthum and A. falconerii in Gomutra, respectively.[24] The cause may be the removal of water and alkali-soluble substances from raw Vatsanabha during soaking treatment. This finding can be explained by mass transfer. The transfer of a soluble mass of solid to liquid occurs through the boundary layer, by molecular diffusion mechanism.[25] The color of Gomutra got changed significantly from yellow to amber. It was due to the removal of brown pigments from the metadarm of the pieces of Vatsanabha.[26] The pH of Gomutra has been found to be reduced possibly due to release of acetic acid and benzoic acid during hydrolysis in Shodhana with Gomutra as it is alkaline in nature. Loss of media has been observed more in the first day due to more absorption of liquid occur in dry state but on subsequent days, the absorption of media is less into the wet material.
The prime objective of standardization and validation is to ensure product uniformity in every aspect, specifically regarding the medicinal activity. In the present study, an attempt has been done regarding pharmaceutical standardization of SV. Thus, five batches of SV were prepared following classical guidelines. Taking [Table 6] into account, it can be elucidated that the pharmaceutical observations have been almost similar in all the batches of SV. The quantity of ingredients for the composition of formulation was kept uniform in all the batches. This may be the reason behind indistinguishable findings. After the application of statistics and calculating the standard deviation of values obtained in each batch, it was observed that they are below 5% variation. As all the results are consistent and in accordance with relevant statistical analysis, it can be said that standardization of pharmaceutical process for preparation of Sanjivani Vati on laboratory scale has been achieved. Nevertheless, the process needs to be verified for large scale manufacturing too. Thereafter, these tablets were assessed for qualitative (sensory) as well as quantitative (physicochemical/physical/sophisticated) evaluation.
Organoleptic parameters
The sensory characteristics (visual, olfactory, tactile, and taste attributes) are an integral part and pilot basis for quality assurance, palatability as well as consumer’s level of acceptability of the product.[27] SV has been found brownish black in color, along with Eshat Tikta (mild bitter) on taste with characteristic odor of Gomutra. Texture of the Vati has been observed smooth.
Physicochemical evaluation
The observations for relevant physicochemical constants of SV have been represented in [Table 7]. The pH of all the batches of SV has been found weakly acidic and within the prescribed standard as per Ayurvedic Pharmacopoeia of India. Gastrointestinal pH has a substantial impact on oral drug absorption and bioavailability as drug dissolution and solubility, drug release, drug stability, and intestinal permeability are all affected by it significantly.[28] The degree of ionization and lipid solubility of a drug are two critical parameters that influence how quickly pharmaceuticals are absorbed from the gastrointestinal tract and how easily they move through cellular membranes. When a weak acid is given orally, the major part of the drug remains unionized in the stomach, allowing for diffusion across the gastric mucosa.[29] Loss on drying (LOD) is the loss of weight expressed in percentage (w/w) resulting from water and volatile matter of any kind that can be driven off under specific conditions. Moisture is an important factor that plays a vital role in the stability of any drug. At instances, the presence of water/moisture will facilitate microbial growth in the product. More moisture percentage may also lead to the hydrolysis of hydrolyzable constituents of formulations. Thus, no or minimum moisture content is advisable in most of the solid formulations.[30] As mentioned in the Ayurvedic Pharmacopoeia of India, LOD for all the batches of SV has been found within permissible limits.
There are two forms of ash viz. physiological ash, which is derived from plant tissue such as carbonates and phosphates, and another is nonphysiological ash, which is derived from external materials such as silicates and silica. Total ash is a mixture of both. It is the ash left behind the incineration process.[31] It has been found more than pharmacopoeial standard (4%). But a previous work also reported 13.76% ash value[32] of SV, almost similar to our study. Acid-insoluble ash is part of total ash, which is insoluble when treated with diluted hydrochloric acid. As a result, it only refers to silica and earthy materials. This value has been found to be conforming with the standards. Water soluble ash has been observed approximately 96%. This value is not prescribed in Ayurvedic Pharmacopoeia of India. Water and alcohol-soluble extractives indicate a particular amount of principle contents that is readily soluble in aqueous and alcohol media. Every drug has a particular number of principal components soluble in different media. This value plays an important role in the evaluation of drugs. Less extractive value indicates addition of exhausted material, adulteration or incorrect processing during drying or storage or formulating.[33] It has been found in compliance with the Ayurvedic Pharmacopoeia of India standard for SV.
Physical tests
Tablet thickness should be controlled within a ±5% variation of a standard value. In this study, the standard deviation (mean ± SD) in the diameter of SV has been found 5.8 ± 0.03 mm. Any variation in tablet thickness may create packaging problems. The physical dimensions of tablets, along with the density of the individual ingredient and their proportions determine the weight of the tablets. Hardness of SV has been found to be 8.94 kg/cm2 with a variation of ±0.45. Hardness parameters give a clue to the compactability and intrinsic strength of powdered materials. These include bonding strength, internal strain, and brittleness. Bonding and strain index are opposite to each other. The higher the bonding index, the stronger the tablet and vice versa for strain index. It is important in the sense that the tablet should not break while transporting or handling or before reaching the consumer.
The average weight of SV was found 130.64 ± 2.43 mg. According to the Ayurvedic Pharmacopoeia,[34] weight variation of 7.5% for tablets weighing 125 mg or more is acceptable. Here, it is within the prescribed limits. Weight variation involves drug distribution uniformity. Friability of SV was found to be 0%. As some formulations, when compressed into very hard tablets, they tend to “cap” on attrition, losing their crown portion; therefore, tablet hardness is not an absolute indicator of strength. Thus, another measure of tablet’s strength, its friability[35] has also been carried out. Conventionally, compressed tablets that lose less than 0.5%–1% of their weight are considered acceptable, as observed in this case. This indicates that the tablet will not crumble, chip, or break upon while handling, coating, or packing. It is important to check the friability of a tablet for complete dissolution in the gastrointestinal tract. The test checks the sturdiness of a tablet.
CHN-O analysis
The CHN(O) analyzer finds utility in determining the percentages of carbon, hydrogen, nitrogen of organic compounds, based on the principle of “Dumas method,” which involves the complete and instantaneous oxidation of the sample by “flash combustion.” Detection and quantification of the gases can be carried out in a variety of ways including gas chromatography separation followed by quantification using thermal conductivity detection. The elemental% in organic compounds present in SV have been represented in [Table 8] and [Figure 4]. The maximum concentration of carbon has been observed in SV followed by hydrogen and nitrogen. Every compound has its own definite chemical structure where carbon, nitrogen, oxygen, and hydrogen are present in a particular ratio. Thus, these results may be used as standards for elemental composition of SV.
Heavy metal analysis
ICP-AES is sophisticated tool, which can detect the presence of metals and minerals in any material. Here, this instrument (Make: SPECTRO Analytical Instruments GmbH, Germany and Model: ARCOS, Simultaneous ICP spectrometer has been opted for heavy metal analysis of SV. Pills were found free from lead [Not more than (NMT) < 10 ppm], cadmium (NMT < 0.3 ppm), mercury (NMT < 1 ppm) as well arsenic (NMT < 3 ppm), which establish its safety for human consumption.
Fourier transform infrared spectroscopy
FTIR is a technique that is used to obtain infrared spectrum of absorption, emission, and photoconductivity of solid, liquid, and gas. In this study, FTIR (Make: Bruker, Germany and Model: 3000 Hyperion Microscope with Vertex 80 FTIR System) has been performed to detect the presence of functional groups or organic ligands and their therapeutic outcomes in SV. It is evident that the same functional group can provide different therapeutic benefits depending upon the drug molecule and the location of that group. It can either increase the selectivity of a drug for one biological target over another or can sterically block metabolism thus increase the duration of action of a specific drug molecule.[36] The spectra [Figure 5] have been taken in the region of 400–4000 cm–1. In the spectra, the peak at 3392.08 corresponded to the O–H alcohol stretch. The Sp3 C–H stretch at 2924.38 indicated the presence of alkane. The peak at 2853.31 cm–1 was caused by C–H stretch, which showed the presence of aldehyde. Moreover, N–H band at 1626 exhibit amide group presence. The peak at 1537.28 represents the presence of nitro compounds with asymmetric stretch. Furthermore, Sp3 C–H stretch can be spotted at 1451.81 and 1377.99. The C–O stretch observed at 1333.05, 1239.81, 1155.81 (strong), and 1027.65 (medium) confirms the presence of acyl and alkoxy groups, respectively. The remaining peaks at 703.61 and 773.66 depict the presence of aromatic compound. Thus, FTIR spectrum revealed the presence of number of functional constituents such as hydroxy, alkane, amide, acyl, alkoxy, and aromatic compounds in SV.
Microbial limit test
Microbial analysis of SV revealed zero total yeast and mold count (NMT < 103/g). Also, the pathogens including Escherichia coli, Salmonella sp., Staphylococcus aureus, and Pseudomonas aeruginosa were found absent. Total plate count was also found in negligible amount of 933 cuff/g, which is observed within the prescribed limit (NMT < 105/g). It indicates toward maintenance of hygiene throughout the whole process, which leads to microbial-free production.
Chromatographic assay
The fingerprint profiles serve as guideline to the phytochemical profile of the drug in ensuring the quality. Phytochemical standardization encompasses all possible information generated with regard to the chemical constituents present in a herbal drug. Here, chromatographic assay of SV has been generated at two wavelengths of 254 and 366 nm. A total of seven spots with Rf viz. 0.14, 0.21, 0.37, 0.46, 0.60, 0.67, and 0.79 have been recorded at 254 nm, whereas nine bands with Rf of 0.07,0.19, 0.25, 0.39, 0.45, 0.53,0.60, 0.66, and 0.76 were visualized at 366 nm [Figure 6] in densitogram scanning [Figure 6].
Gas chromatography-mass spectrum analysis
The objective of GCMS was to analyze the components present in SV and the evaluation of pesticide residue as well. The compounds present in the samples were identified by comparing peaks with standards available in the spectral library attached to the GCMS instrument (Make of GC: Agilent 7890, FID detector, Head Space injector, combinal autosampler, Make of MS: Jeol and Model: AccuTOF GCV). A total of 21 components [Table 9] and [Figure 7] were detected in SV excluding the first peak of solvent, that is, hexane (C6H14) having retention time of 4.18. The families of identified compounds included 11 hydrocarbons, 5 esters, and 1 phenylpropanoid, that is, cis-Asarone. Cis-Asarone could attenuate neuronal autophagy, reduces inflammation, thus increasing cell viability.[37] It is noted for its neuroprotective effects, as it ameliorates depression, reduces dopamine-induced neurotoxicity, and attenuates damage in a model of stroke.[38],[39] Its antifungal property[40],[41] has also been reported. It has been possibly coming from sweet flag (Vacha) utilized in the preparation of drug. Apart, another identified compound, Heptacosane is also a potential biomarker know for its antimicrobial activity against Proteus mirabilis and Bacillus subtilis[42] Apart, palmitic acid also plays a critical role in supporting normal cellular membrane function, in addition to helping the body store energy to facilitate metabolic functions.[43] However, it needs to be consumed in balance with unsaturated fatty acids, especially polyunsaturated fats. Similarly, each observed metabolite possesses a distinct medicinal role. Also, each component had different retention times except for 2,4-dimethyldecane, sulfurous acid, and 2-propyl tridecyl ester, which were detected at two different retention times. This is a preliminary report and further work should be carried out to prove therapeutic outcomes of this medication.
Furthermore, this analysis marked the absence of pesticides viz. Aldrin, dichlorodiphenyltrichloroethane, Endodulfan, benzene hexachloride, Lindane, Chordane, Dieldrin, Chlorpyrifros, Dimethoate, Malathion, Methyl parathion, Quinolphos, and Cypermethrin. Generally, when the raw material is cultivated, organophosphorus is the major class of pesticides found as contamination. As they are hazardous to health, their estimation in the final product becomes essential from the point of view of quality control and standardization. These values signify toward good manufacturing practices followed during preparation of SV.
| Conclusion | | |
This kind of determination somehow provides a complete overview of pharmaceutical standardization as well as validation of analytical specification of SV, and thus could be used as model data for future references. Nevertheless, extensive studies along with the application of chemometrics may be helpful in extracting more useful and additional information. Moreover, further research work should be carried out to explore the therapeutic outcomes of this medication.
Acknowledgment
The authors would like to acknowledge the support extended by Dr. Rohit Singh, Assistant Professor, Department of Rasashastra and Bhaishajya Kalpana, Shri Dhanwantari Ayurvedic Medical College & Research Center, Semri, Mathura, Uttar Pradesh, and are sincerely thankful to the management of Sophisticated Analytical Instrument Facility, IIT Bombay and Vasu Healthcare Pvt. Ltd. for the state-of-the-art testing facility to carry out this work.
Financial support and sponsorship
This work was supported by All India Institute of Ayurveda, New Delhi, India.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9]
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