Abstract

PHARMACEUTICAL AND ANALYTICAL STANDARDIZATION OF KIRATATIKTADI GHANA VATI: A GMP PERSPECTIVE

Dr. Maltee Patel*, Dr. Manish Kumar Patel and Dr. Varun Gupta

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Abstract

Introduction: This study aims to standardize and validate Medopachak Yoga, focusing on its Ghana Vati (tablet) form. Medopachak Yoga comprises Kiratatikta (Swertia chiraita), Guduchi (Tinospora cordifolia), Raktachandana (Santalum album), and Shunthi (Zinziber officinalis), traditionally used in treating "Vishamjwara" (fever) as described in the Jwara Chikitsa Adhyaya. The necessity for high-quality Ayurvedic products in response to the global demand for herbal treatments, emphasizing the importance of consistent dosage forms, is addressed. Methods: The pharmaceutical procedure involved decocting the ingredients, creating a fine powder, and forming tablets of 500 mg each. The physico-chemical analysis included tests for parameters such as color, odor, taste, loss on drying, total ash, watersoluble ash, and others. Microbiological tests were conducted to ensure the absence of harmful microorganisms. Results: The analysis confirmed the quality and consistency of the tablets. Tests showed the following results: color (buff), odor (characteristic), taste (bitter), loss on drying (0.24%), total ash (4.73%), water-soluble ash (3.12%), acidinsoluble ash (0.27%), water extractive value (15.77%), alcoholsoluble extractive (9.31%), pH (4.6), disintegration time (3.2 min), hardness (3.2 kg/cm²), friability (0.5%), and absence of total viable count, Enterobacteriaceae, total fungus count, E. coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa. Discussion: Tablets offer advantages such as precise dosing, ease of administration, and convenience. The successful validation of Kiratatiktadi Ghana Vati, adhering to GMP norms, ensures the medicine's safety, efficacy, and consistency. The processing sequence adhered strictly to GMP norms, with changes documented at every stage from raw material pulverization to the final packaging of the product. Conclusion: The standardization of Kiratatiktadi Ghana Vati has been confirmed through validation using both Ayurvedic and modern physico-chemical parameters. This validated method ensures optimal efficacy of the finished product during its preparation. Across all three batches prepared, no significant variations were observed, demonstrating consistency in meeting quality parameters. This study provides a reliable reference for future research on this Ayurvedic formulation.

Keywords: GMP (Good manufacturing practice), Pachak Yoga, Kiratatiktadi Ghana Vati, Pharmaceutical standard.