Accelerated Stability Study of Kailas Jeevan – A Proprietary Ayurvedic formulation

Abstract

Background: Stability studies are the test to assess the shelf life of the Ayurvedic proprietary medicines. Govt. of India made mandatary test for licencing and renewal of licencing of the proprietary medicine. Accelerated stability studies, testing interval of 0,3 and 6 months.  Kailas Jeevan is a proprietary semisolid dosage form prepared in GMP approved Ayurveda Sumshodanalaya (P) Pvt. Ltd. Dhayri, Pune. It is indicated in Constipation, Cracked heels, Wounds, Pimples, Burns etc. Aims and Objectives: To evaluate the shelf life of Kailas Jeevan through accelerated stability study. Materials and Methods: The formulation was prepared in the GMP approved pharmacy. Shelf life of product was evaluated by assessing in changes in physicochemical, Microbial and quantification profiles, after keeping it in stability chamber at specific temperature (40±2°C) and relative humidity (75±5%). Analysis was carried out at the intervals of 0, 1, 3, 6, 9,12, 18 and 24 months. Average 25% degradation time was calculated to find the shelf life as per the Ayurvedic Pharmacopoea of India, Part I Vol ix guidelines. Results and Conclusion: The parameters assessed in accelerated study of Kailas Jeevan, was shown under limits till 24 months. Based on multiplication factor shelf life of Kailas Jeevan is 7.02 year. Key Words: Stability, Shelf life, Kailas Jeevan, Accelerated stability study