STANDARDISATION AND STABILITY STUDY OF AYURVEDIC FORMULATION- TRIPHALA CHURNA AS PER THE ICH GUIDELINES.

The research focused on standardizing Ayurvedic formulations, specifically targeting Triphala churna, a complex multi-ingredient traditional medicine. In the context of increasing interest in Ayurveda's potential medical benefits, this study addresses the critical need for comprehensive guidelines as to those in allopathic medicine for formulating, ensuring quality, establishing safety profiles, and assessing efficacy in Ayurvedic preparations.The primary objective is to standardize Triphala churna using High-Performance Thin-Layer Chromatography (HPTLC) and to evaluate the formulation's stability and quality, Forced Degradation studies were performed according to ICH guideline Q1A(R2) and Q 2 (R1), focusing on two marker compounds, Gallic acid, and ascorbic acid. There was a comparative analysis between an in-house Triphala churna preparation and a commercially available product to determine the concentration of these marker compounds.The study reveals specific wavelengths for marker compounds and demonstrates a decrease in their concentrations after forced degradation. The significance of standardizing Ayurvedic formulations to ensure their quality, efficacy, and safety. It also highlights the successful development of a validated method to assess the stability profile of Triphala churna. The mobile phase Toluene:Ethyl acetate:Formic acid (6:3:1) was selected for HPTLC due to its efficient separation capabilities.The research indicates that Gallic acid remains stable under acidic and oxidative conditions but not under alkali hydrolysis, in accordance with ICH guidelines. Ascorbic acid's stability under basic and oxidative conditions warrants further investigation. Overall, this study makes a valuable contribution to advancing the standardization of Ayurvedic formulations, with promising results regarding Triphala churna's stability under various stress conditions, including ICH-compliant testing methodologies.