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STANDARDISATION AND STABILITY STUDIES OF AYURVEDIC FORMULATION- TRIKATU CHURNA AS PER ICH GUIDELINES
* 1 , * 1 , * 2
1  Department of Pharmaceutical science and Technology,BIT MESRA,RANCHI-835215
2  Associate Professor, Pharmaceutical Sciences and Tech M. Pharm., Ph.D., R.Ph. Gmail: manik@bitmesra.ac.in
Academic Editor: Julio A. Seijas

https://doi.org/10.3390/ecsoc-28-20160 (registering DOI)
Abstract:

World is moving back towards the root of medical advancement which is Ayurveda, but the issue faced during Ayurvedic medicine development is that there is no specific guideline for formulation, development, quality assurance, defining the safety profile, and assuring the efficacy of the Ayurvedic formulation as for allopathic medicine. Due to the unavailability of data regarding particular target-based Efficacy or mechanism of action of particular ingredients. This research is based on performing standardization of Ayurvedic formulation i.e., Trikatu Churna using HPTLC Instrument and carrying out force degradation studies of the Churna extract by using Piperine and Quercetin as marker compound according to ICH guidelines Q1A (R2) and Q2R1). In-house Trikatu was compared to the marketed Trikatu for analyzing the concentration of piperine and Quercetin in the churna. The presence of these chemicals in churna was marked by comparing the Rf value with Marker compounds which was found to be 0.64 for piperine and 0.51 for Quercetin..Forced degradation data showed the loss in concentration of both pure marker compound and in house Trikatu Churna as well as marketed churna.Standardization was done and validated method for standardization and estimated the Stability profile of same. The wavelength is identified for both marker compound and degradation study showed that there was decrease in concentration of marker Compound both in house Trikatu churna and as well as marketed Churna . The use of Standardization for Ayurvedic formulation discussed and validated method is developed and the stability profile of the Trikatu churna is estimated.

Keywords: Degradation: Stability: ICH: Safety: Efficacy

 
 
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