ACCELERATED STABILITY STUDY OF CHITRAK HARITAKI AVALEHA
Objective: Accelerated stability study of Chitrak Haritaki avaleha was done for six months to know the stability of formulation in reference of its phyto-constituents and microbial growth therein.
Methods: Chitrak Haritaki avaleha was made in laboratory following classical method [Sample lab (SL)] as per AFI part-1(The Ayurvedic formulary of India, part-1) and two samples were collected from local market [Market Sample-1(MK-1) & Market sample-2 (MK-2)] of reputed brand. These three samples were put in controlled condition following ICH (International Conference on Harmonization) guidelines for accelerated stability study for six months. The intermediate samplings were done at starting, after one, three and six month respectively. These samples were investigated for reducing sugar, phyto-constituents (Total tannins, piperine, vitamin C and total polyphenols contents), microbial load and their organoleptic characteristics.
Results: All the results were calculated and compared for variation during course of time. Variation in the result of samples was evaluated against Arrhenius equation which ensured that formulation was stable over two years and no significant variation was found over six month of accelerated stability condition.
Conclusion: Since it is traditional avalehakalpana, the shelf life period was about one year (Sharangdhar Samhita) and updated to three year in Drug and cosmetic rule 1945, 161B. The presented study reflect that Chitrak Haritaki avaleha was stable over two year (by taking inference from Arrhenious equation) and more sophisticated packing may improve the shelf life period.Keywords: Avaleha, Shelf life, Accelerated stability, Chitrak Haritaki avaleha.
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