S. Saraf

Validation of Preparation Process and Development of Fingerprints for Ayurvedic Formulation Arjunaristha by High Performance Thin Layer Chromatographic Estimation of Gallic Acid

Arjunaristha (AJR) is a classical Ayurvedic formulation used as general tonic for heart disease, lung diseases, loss of strength, immunomodulator and in azoospermia. It is observed that the consistency and taste of the formulation varies from manufacturer to manufacturer. Hence, it is need of the hour to develop standardized preparation process and validation, with the advent of new analytical tool and sophisticated instrumental technology. Three batches of AJR were prepared in the laboratory according to method given in Ayurvedic formulary of India and three marketed samples procured from local pharmacy. Process validation was developed with the help of physiochemical and chromatographic studies at every step of the preparation process. AJR contains Terminalia, Arjuna and Woodfordia flaburanda, containing gallic acid as main active constituents. The high performance thin layer chromatographic method has been developed for the fingerprinting of AJR. The result of different stage samples (laboratory) found in close proximity, while finished formulation and marketed samples showed little deviation. The methods used for validation of preparation process and fingerprinting were found to be precise and reproducible and can be used for the routine process validation and fingerprinting of AJR.