Assessment of standardization and quality control parameters of a new formulation of Trijata; An Ayurveda formula

Abstract

Trijata is a polyherbal Ayurveda preparation containing Twak (Cinnamomum verum syn. Cinnamomum zeylanicum), Ela (Elettaria cardamomum), and Patra (Cinnamomum tamala) discussed in Ayurveda textbooks, including Bhava Prakash, Kaiyadeva Nighandu and Ayurveda Pharmacopeia, Sri Lanka. This study aimed to develop a novel preparation of Trijata incorporating C. zeylanicum leave substituting Cinnamomum tamala, due to the unavailability of C. tamala in Sri Lanka. Furthermore, quality control and standardization parameters were developed for this Novel Trijata (NT). The hot and cold aqueous extractions were subjected to qualitative phytochemical screening. Total phenolic, flavonoid contents, and in-vitro antioxidant activity were determined using DPPH and ABTS assays. Microbiological limits, heavy metal content, and physicochemical parameters including; the ash content, and extractable matter were determined for quality control and standardization. Preliminary phytochemical analysis revealed the presence of phenols, flavonoids, tannins, alkaloids, saponins, terpenoids, reducing sugars, and cardiac glycosides in NT aqueous extract. The physicochemical parameters including; 4.6±0.2% of total ash, 3.1±0.1% water-soluble ash, and 0.6±0.2% of acid insoluble ash on a dry weight basis were determined. In-vitro antioxidant activity as per DPPH and ABTS assays was dose-dependent and the highest activity was obtained with IC₅₀ of hot water extract. Extractability was high for hot extraction. NT had high total phenolic and flavonoid content exhibited through promising antioxidant activity. The microbiological limits and heavy metal content were within the standard acceptable limits. The HPTLC profiles of this study would be more helpful to authenticate this product (NT) for drug manufacture and further studies are recommended to evaluate its biological activities for proper indications.