STANDARDISATION & STABILITY STUDIES OF AN AYURVEDIC FORMULATION- HINGVASTIKA CHURNA AS PER ICH GUIDELINES

The world is gradually moving back towards Ayurveda, the root of traditional medical advancement. However, Ayurvedic medicine development faces challenges due to the absence of standardized guidelines for formulation, quality assurance, safety profiling, and efficacy evaluation, unlike allopathic medicine. This gap has resulted in limited data on target-based efficacy or mechanisms of action, especially since most Ayurvedic formulations are polyherbal in nature.

The present study focuses on the standardization of an Ayurvedic formulation, Hingvastika Churna, using HPTLC and performing forced degradation studies on its extract. Piperine and Ferulic acid were selected as marker compounds, and the study was conducted in accordance with ICH guidelines Q1A (R2) and Q2 (R1). An in-house prepared Hingvastika Churna was compared with a marketed formulation to analyze the concentration of these markers. The presence of piperine and ferulic acid was confirmed by comparing the Rf values of the samples with standard markers, which were 0.5 and 0.38, respectively.

After method development and validation, forced degradation studies on both formulations and individual ingredients showed notable losses in concentration under stressed conditions. Acidic conditions resulted in the highest degradation of piperine (38.91%) and ferulic acid (60.96%), followed by oxidative and basic conditions. Piperine showed 35.42% and 35.84% degradation, while ferulic acid showed 39.24% and 39.07% degradation in basic and oxidative conditions, respectively.

This study emphasizes the importance of scientific standardization and stability profiling in Ayurvedic formulations to ensure safety, efficacy, and quality consistency.