Evaluation of Quality and Safety Parameters of Shenbagathi Mathirai Using PLIM Guidelines

Abstract

Shenbagathi Mathirai is a classical Siddha polyherbal formulation indicated for its laxative action. Analytical evaluation is necessary to determine its pharmaceutical quality and safety. Objective: To evaluate the physicochemical characteristics and safety parameters of Shenbagathi Mathirai prepared according to Siddha literature. Materials and Methods: The formulation was prepared using authenticated raw materials including Michelia champaca, Syzygium aromaticum, Costus speciosus, Elettaria cardamomum, Glycyrrhiza glabra, and purified Croton tiglium. Organoleptic and physicochemical parameters such as loss on drying, ash values, extractive values, pH, uniformity of weight, and disintegration time were assessed as per PLIM guidelines. Safety parameters including heavy metal analysis (AAS), microbial load, specific pathogens, pesticide residues, and aflatoxins were also evaluated. Results: The formulation showed acceptable physicochemical characteristics with loss on drying (8.3%), total ash (0.89%), water-soluble extractive value (10.53%) and alcohol-soluble extractive value (6.66%) and pH (7.5). Heavy metals were not detected. Microbial load, specific pathogens, pesticide residues, and aflatoxins were not detected. Conclusion: The findings confirm that Shenbagathi Mathirai complies with established quality and safety standards, supporting its suitability for therapeutic use.