Shelf Life Evaluation and Comparative HPTLC Profile of Lekhaniya Mahakashaya Siddha Taila–A Preliminary Assessment

Abstract

Background: Lekhaniya Mahakashaya Siddha Taila (LMST) is a herbal formulation containing 10 herbal drugs, i.e., Lekhaniya Mahakashaya Gana mentioned in the Charak Samhita Shadvirechana Shatashritiya chapter. This is an important formulation in Ayurveda therapeutics, but its shelf life is not evaluated till date. The Government of India Gazette specifies the shelf life of various Ayurvedic medicines. However, there is a need to revalidate the shelf life of individual formulations by following parameters prevalent in the respective scenario. Considering this, it is planned to evaluate the shelf life of LMST. Materials and methods: Taila was prepared following classical guidelines. The samples were subjected to the accelerated stability study maintaining temperature and humidity 40 ± 2 °C and 75 ± 5%, respectively. Relevant analytical parameters were analyzed at an interval of 0, 1, 3, and 6 months to check the degradation levels in the formulation. The 10% degradation was set as the acceptable point to extrapolate the accelerated stability data. Real-time aging factors 5 and 3.3 were used for the extrapolation of shelf life for climatic zone I and II countries and climatic zone III and IV countries, respectively. India comes under climatic zones III and IV. The formula for the calculation of shelf life given in the manuscript and International Council for Harmonisation (ICH) guidelines are used for conducting the shelf life study. Results: The microbial contamination and heavy metals were found to be within the prescribed limits. There were insignificant changes in physicochemical profiles at different intervals. On extrapolation of the observations, the shelf life of Taila was found to be 4 years. Conclusion: The shelf life of LMST was found to be longer than the given standards in official Gazettes of Government of India. This observation may be exclusive to LMST Studies on other Tailas need to be carried out to confirm this preliminary observation.