Shelf Life Evaluation of Shirishavaleha and its Granules

Abstract

Background: Shelf life is the length of time, after which all substances start to degrade in their qualities and become unsuitable for consumption or sale. Every product has definite shelf life, which depends on various physical, chemical, environmental, and biological factors. Shelf life of various compound formulations was clarified in the classical text. So there is a need to revalidate and establish the shelf life of individual formulation. As the Government of India made it mandatory to display in the labels the shelf life of all products, it becomes essential to evaluate the actual shelf life of individual products by following the specified guidelines. Aim: To evaluate the shelf life of Shirishavaleha (SHA) and its granules prepared with Khanda Sharkara through accelerated stability parameters. Materials and methods: Physicochemical parameters of SHA and Shirishavaleha granules (SHG) were calculated by maintaining 40°C ± 2°C temperature and 75 ± 5% relative humidity at the intervals of 0, 1, 3, and 6 months. Based upon the observations, intercept, slope, 10% degradation of the sample, and finally the shelf life were calculated. Results: Accelerated stability study reveals the shelf life of SHA as 5.9 years, while that of the granules as 5.3 years. Similar Rf values obtained in high-performance thin-layer chromatography (HPTLC) analysis of both samples initially and after 6 months showed minimum deterioration of the product. Microbial count and heavy metals were below the permissible limits in both the samples. Conclusion: Guidelines specified in the Drugs and Cosmetics Act, 1940, mentions 3 years as the shelf life of Avalehas and granules. This time period is general, and different formulations may have different shelf lives based upon the factors such as their composition, etc. The samples tested in the current study, i.e., SHA and SHG, are found to have a shelf life of 5.9 and 5.3 years, respectively, through accelerated stability study that are almost double the average time specified in the guidelines.