Evaluation the Accelerated Stability of Dadrughni Vati (Lepa) and Dadrughna Malahara: A Comparative Approach
Abstract
Introduction: The shelf life and stability of traditional herbal formulations are essential for their efficacy and safety. Stability studies of Dadrughni Vati (Lepa) (DL) and its modified form, Dadrughna Malahara (DM), have not been conducted. This study evaluates their shelf life under accelerated storage conditions per ICH guideline Q1A, analyzing organoleptic, physicochemical, microbial, and chemical stability parameters.
Methods: DL and DM were stored under accelerated conditions for six months, with stability assessments at 0, 3, and 6 months. Evaluations included organoleptic properties (color, texture, odor), physicochemical parameters (pH, extractive values, moisture content for DL; specific gravity, iodine value, acid value, viscosity, spreadability for DM), microbial contamination (total plate count, yeast and mold, pathogens), and chemical stability through HPTLC fingerprinting at 254 nm, 366 nm, and 540 nm. Shelf life was estimated using degradation curve analysis.
Results: Both formulations remained stable in organoleptic properties. DL exhibited changes in pH, extractive values, and moisture content, while DM showed increases in specific gravity, iodine value, and acid value. The microbial limit test confirmed pathogen-free status. HPTLC analysis indicated consistent chemical composition without significant degradation.
Conclusion: DL and DM demonstrated stability under accelerated conditions, with slight physicochemical variations. Shelf-life estimates suggest DL is stable for 6.89 years and DM for 3.59 years in climate zones III and IV, ensuring their quality and therapeutic efficacy.
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References
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