ABSTRACT:
Background: Vaisvanara Churna a classical Ayurvedic polyherbal formulation used to treat fever, constipation, arthritis and diseases of digestive tract. Being a popularly used drug, there is a need to set quality standards and shelf life for this formulation. Objective: The objective of the study is to set standards for quality control and shelf life of Vaisvanara Churna. Materials and Methods: All the raw drugs were identified, authenticated and screened for microbial quality. The quality passed raw drugs were used for preparation of churna as per Ayurvedic Pharmacopoeia of India. Then the formulation was screened for pharmacognostic, physico-chemical, HPTLC finger printing properties. The prepared formulation was stored in the environmental chamber at 30°C± 2°C/60%±5% RH as per the ICH guidelines for real time stability studies for the climatic zone IV. Representatives of stored formulation were tested periodically (0, 3, 6, 9 and 12 months) for microbial quality, physico-chemical properties and HPTLC. Results: The formulation was prepared from the quality passed raw drugs. Powder microscopy analysis revealed the presence of micro structures of raw drugs in the finished product. Physico-chemical properties and microbial quality were found to be within the API limits. HPTLC finger printing revealed the presence of chebulinic acid, gingerol and thymol in the finished product. Shelf life studies revealed stability of the formulation throughout the period of testing. Conclusion: The present study tested the parameters required for setting quality standards for Vaisvanara Churna and found to be stable in real time stability testing.