Abstract

R. S. Yashica*

ABSTRACT

Asphaltum punjabianum Shilajit, a revered substance in Ayurveda, faces significant challenges in its transition to modern therapeutics due to quality variability, safety concerns, and poor bioavailability. This project aimed to address these limitations through a comprehensive strategy involving chemo-standardization, safety validation and bioavailability enhancement. Fifteen Shilajit batches from different geographical regions were analyzed using FTIR, HPTLC and a newly developed and validated HPLC method for quantification of key biomarkers like dibenzo-α-pyrone and fulvic acid. ICP-MS confirmed that purified batches contained heavy metals below WHO/USP safety limits. To overcome bioavailability issues, a novel Shilajit-phospholipid complex was developed, which demonstrated a ~3.5-fold increase in lipophilicity and a remarkable enhancement in in vitro dissolution (>85% release in 4 hours vs. 35% for native Shilajit). The complex showed optimal nanometric particle size (215.4 nm), high stability (Zeta potential: -32.6 mV), and remained stable under accelerated storage conditions. This research establishes robust standardization protocols and introduces an advanced delivery system for Shilajit, effectively bridging traditional use with evidence-based modern medicine and paving the way for its reliable therapeutic application.