Abstract

Background: Agnimantha Shilajatu Yoga, referenced in Charaka Samhita and Chakradatta, is known for its anti-obesity potential.Despite its historical and clinical importance, its usage decreases due to the unavailability of authentic Shilajatu, the limited availability of Agnimantha, and the time-consuming nature of preparing Kwatha as a dosage form. This study involves the analytical evaluation of Agnimantha Shilajatu Yoga for the preliminary monograph development of this formulation. Based on its analytical profile, the study aims to demonstrate its phytochemical-based rationale. Materials & Methods: The purification (Shodhana) of Shilajatu was conducted using Triphala Kwatha. The processed Shilajatu was then triturated with the decoction of Agnimantha (Premna integrifolia Linn.). Analytical evaluations were performed on Ashodhita Shilajatu (raw), Shodhita Shilajatu (processed), and Agnimantha Twaka Kwatha Bhavita Shilajatu. These evaluations included an organoleptic profile, phytochemical and physicochemical analyses, HPTLC, FTIR, estimations of fulvic and humic acids, as well as advanced analytical techniques (CHNS-O, LC-MS, ICP-AES, FEG-SEM) along with microbial counts. Results: Phytochemicals such as saponins, tannins, alkaloids, proteins, and flavonoids were present in the Agnimantha Shilajatu yoga. Fulvic acid was found to be 3.28%. The HPTLC analysis revealed distinct chromatographic profiles at different wavelengths. In the FTIR analysis, Ashodhita Shilajatu exhibited 18 peaks, and Shodhita Shilajatu showed 11. Agnimantha Twaka Kwatha bhavita Shilajatu exhibited 7 peaks. The elemental analysis of Agnimantha Twaka Kwatha Bhavita Shilajatu samples using FEG-SEM-EDS & ICP AES indicates the presence of Al, Mg, Si, Cl, K, Ca, Fe, Cu, Zn. Total microbial count yielded negative results, ensuring the safety of the formulation. Conclusion:. This study develops a user-friendly pharmaceutical dosage form manufactured under the umbrella of Ayurvedic principles while ensuring replicability and facilitating large-scale industrial production. Based on its analytical profile, the study aims to demonstrate its phytochemical-based rationale, supporting the therapeutic potential of this classical Ayurvedic formulation in addressing obesity and related metabolic disorders.

Key words: Agnimantha, Shilajatu, Premna integrifolia Linn., Fulvic acid, Bhavana