Shelf-Life Evaluation and Comparative High-Performance Thin-Layer Chromatography Profile of Amavatari rasa: A Preliminary Study

Abstract

ABSTRACT Background: In addition to safety and efficacy data, it is important to establish quality parameters for all drugs, including shelf life. Shelf life is the length of time that a product may be stored without becoming unfit for use, consumption, or sale. Every product in this universe has a definite shelf life. In Ayurveda texts, shelf life is known as Saviryata avadhi that is defined as the time period during which the potency (Virya) of any drug remains unaffected. Amavatari Rasa (AR) is an important formulation being used in Ayurvedic therapeutics; however, its shelf life is not reported till date. Aims and Objectives: This study aimed to evaluate shelf life of AR through accelerated stability study. Materials and Methods: Accelerated stability study and comparative high-performance thin-layer chromatography (HPTLC) profile were done to evaluate the shelf life of the AR. The formulation was prepared by using authentic raw material in the departmental laboratory by the following classical guidelines. It was evaluated by analyzing changes in physicochemical profiles of the product after keeping it at specific temperature (40°C ± 2°C) and relative humidity (75% ± 5%). Analysis was carried out at the intervals of 0, 3, and 6 months. Average 10% degradation time was calculated and extrapolated to find the shelf life as per the ICH guidelines. Results and Conclusion: In the present study, shelf life of AR was found to be 48 months; similar Rf values obtained in HPTLC analysis of AR initially and after 6 months showed the minimum deterioration of the product.