ANALYTICAL ASSESSMENT OF CHEMICAL STABILITY AND SHELF-LIFE OF GOKSHURA CHURNA: A SCIENTIFIC APPROACH

Objective: Gokshura Churna is a versatile Ayurvedic remedy with a rich history of therapeutic use in promoting urinary, reproductive and physical health, it holds a significant place in traditional medicine. However, to ensure its long-term efficacy and safety, especially in modern applications, it is essential to support its use with scientific validation, particularly in terms of quality, stability and shelf-life. Methods: The present study focuses on determining the shelf-life of Marketed Gokshura Churna formulation using reverse phase high performance liquid chromatography (RP-HPLC) method. Stability testing was conducted under both accelerated and long-term conditions, following international council for harmonisation of technical requirements for pharmaceuticals for human use (ICH) guidelines. Samples were analyzed at intervals of 0, 1, 3, 6, 9 and 12 mo. The chemical fingerprint of the formulation was established by using two analytical Markers Quercetin and Beta-sitosterol. In addition to chemical analysis, various quality control parameters were evaluated as per the Ayurvedic Pharmacopoeia of India (API), including organoleptic properties, Loss on drying, ash content, extractives values, pH and microbial load. Results: Quercetin and Beta-sitosterol were eluted at 5.7 and 7.8 min. The overall results of the validation parameters of the Markers were within the limits. Stress studies confirmed the absence of co-eluting peaks and degradants under various stress conditions. All the Physicochemical parameters of the formulation were within the acceptable limits. Total microbial load analysis of the formulation showed that the bacterial count was within acceptable limits, while there is a marginal increase in the fungal count was observed. Based on the stability analysis of Quercetin and Beta-sitosterol marker content, the shelf life of Gokshura churna was estimated to be 29.80 and 26.20 mo. Conclusion: This study provides a scientific foundation for future commercial stability testing and contributes to improved quality and safety of Gokshura churna.