Stability testing of Ayurvedic formulations: Exigency of today’s world

Abstract

The concept of stability is one of the most important issues regarding Ayurvedic formulations as till date no specific guidelines are available for the same. Although the Ayurvedic lexicon as well as Gazette notification issued by Government of India on 26th November, 2005 revealed shelf life of Ayurvedic formulations, greater advancements in packaging and storage technology nowadays has created a need for the revision of their shelf life. Mainly, two guidelines, namely, International Conference on Harmonization (ICH) and the World Health Organization provide details regarding parameters for stability study of pharmaceutical products but ICH guidelines from Q1 to Q11 is generally followed. A well-designed stability protocol containing information such as selection of batches and samples, test attributes, analytical procedures, acceptance criteria, storage conditions and period, testing frequency, sampling plan, container closure systematic, and various types of stability study and stability testing methods should be taken into consideration. Currently, pharmaceutical product is generally assayed using a validated stability indicating analytical method and an expiry date is marked based on the predicated period from date of manufacture when the pharmaceutical product would show more than 10% deterioration in the active molecule. Hence, these guidelines may also be implemented on Ayurvedic formulations where percentage degradation can be assayed when the product is stored at different conditions of temperature and humidity. The general concept of stability for Ayurvedic or modern medicine remains same but the parameters used to assess the stability may vary from product to product.