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Year : 2023  |  Volume : 8  |  Issue : 3  |  Page : 230-241

Pharmaceutical standardization and analytical validation of Sanjivani Vati

Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi, Delhi, India

Correspondence Address:
Dr. Shreshtha Kaushik
Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi 110076, New Delhi
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jdras.jdras_77_22

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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.

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