Assessment of Quality Control parameters under Accelerated Stability Conditions for Manasamitra Vatakam; A Herbo Mineral Formulation

Accelerated Stability Studies predicts the stability data and significantly explains the drug decision process. In the present study, Manasamitra Vatakam, a Herbo mineral formulation was subjected to stability conditions at 40°C ± 2°C /75%± 5% RH for 06 months. Control and stability samples were determined for parameters like Weight variation, Moisture content, Marker content determination, and Disintegration test, Dissolution study with different mediums, Friability and Hardness test. The phytomarker analysis showed decrease assay value for β-sitosterol, Vitexin, Kampferol and Withaferin. The dissolution studies were performed for the major biomarker Berberine in 0.1N HCl, pH 4.5 acetate and pH 6.8 phosphate buffer in which pH 6.8 buffer showed maximum release of 66.82% at 04 hours. The other Quality control parameters showed minimal difference under acceptance criteria. The study explains the need of stability analysis in polyherbal formulations and developed method can be used for routine analytical studies in various formulation containing berberine. Keywords: Berberine, HPLC, Manasamitra Vatakam, Quality Control, Stability.