STANDARDISATION AND HPTLC METHOD DEVELOPMENT OF MARKETED AYURVEDIC FORMULATION – BALARISHTA
Abstract
Objective: The present study aims to standardize four marketed brands of Balarishta, an Ayurvedic formulation viz. Baidyanath-Balarishta (BB), Dabur-Balarishta (DB), Zandu-Balarishta (ZB) and Nagarjuna-Balarishta (NB) with respect to their physicochemical (organoleptic properties, pH, specific gravity, total solid content, ethanol content, reducing and non-reducing sugar content), phytochemical and microbial parameters (total bacterial count, total fungal count and test for specific pathogens viz. P. aeruginosa, E. coli and S. aureus). It also aims to develop and validate a new highperformance thin layer chromatography (HPTLC) method for simultaneous determination of three major phytoconstituents present in Balarishta viz. withaferin A, gallic acid and ephedrine.
Methods: ‘Protocol for testing Ayurveda, Siddha and Unani medicines' was used as a reference for conducting standardization experiments. HPTLC method was developed on Camag Linomat-5 using silica gel 60 GF254 as the stationary phase and Toluene: Chloroform: n-propanol: Ethanol: Formic acid (6: 3: 1: 2: 1, v/v/v/v/v) as the mobile phase. The analytical method validation studies were performed as per International Conference on Harmonization-Quality (ICH-Q2 (R1)) guidelines.
Results: The results of standardisation tests obtained were compared with specifications mentioned in ‘Ayurvedic Pharmacopoeia of India 2008 Volume 2, Part 2' and a comparative data of each Balarishta formulation was generated for all the quality control parameters performed. A new, accurate, precise and robust HPTLC method was successfully developed with Retardation factor (Rf) of 0.17±0.02, 0.35±0.01 and 0.54±0.02 for ephedrine, gallic acid and withaferin A respectively.
Conclusion: The results of this research work will serve as a valuable quality tool for routine quality control analysis of Balarishta formulations.
Keywords: Balarishta, Standardisation, Withaferin A, Gallic acid, Ephedrine and HPTLC.
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References
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