ACCELERATED STABILITY STUDY OF KHAMIRAE ABRESHAM SADA

The stability forms an important component of quality assurance program which involves the implementation of systems and procedures that provide a high probability that each dose or package of a pharmaceutical product have homogenous characteristics and properties which ensure both chemical safety and efficacy of that product. Stability studies are paramount requirement for finished pharmaceutical product for its registration, quality control assurance, prediction of shelf life and expiry dates. This study has furnished the feasible methods for evaluating shelf life of Unani Drugs. Accelerated Stability Study for 6 months of Unani formulation Khamirae Abresham Sada was done. The drug was prepared, packed and kept in stability chamber at 400C and 75% RH and then analyzed for organoleptic, physical, chemical and microbiological parameters. Samples were analyzed at 0, 3 and 6 months. Formulation was assessed for organoleptic characters, physical, chemical and microbiological changes. High Performance Thin Layer Chromatography (HPTLC) with multiple wavelength densitometric scanning was done. The findings showed degradation changes in drug formulation. The present study showed that the shelf life of Khamirae Abresham Sada was found to be 10 months to 1 year. The data collected at Accelerated Stability Study can be extrapolated for intermediate, long term, bracketing and matrixing so that better storage conditions for these two drugs can be recommended.