Author(s):

Biswajyoti Patgiri, Hardik Soni*, Surendra Bhatt

Abstract: The objective of the present study was to evaluate stability study of Rasayana Churna. Accelerated stability study (Temperature: 40 °C ± 2, Relative Humidity (RH): 75% ± 5) and real time stability study (Temperature: 25 °C ± 2, Relative Humidity (RH): 60% ± 5) was conducted as per ICH guideline Q1A (R2). The change in organoleptic parameters, physic-chemical parameters and microbial load was observed 6 month for accelerated stability and 1 year for real time stability study at an interval of 0,1,3,6 and 12 months. Real time stability was comparatively carried out to evaluate actual degradation rate of Rasayana Churna with respect to accelerated condition. No change was observed in color, odour and taste of Rasayana Churna up to storage of 6 months at accelerated condition. Results of different physico-chemical parameters were taken in consideration to evaluate intercept and slope. Extrapolated shelf life of Rasayana Churna was calculated with 10% degradation rate from physico-chemical parameters at accelerated condition 40 °C ± 2 and 75% ± 5 RH. The present investigation supports that the Rasayana Churna was suitable at accelerated condition up to 6 month storage. it can be extrapolated that shelf life of Rasayana Churna is 25.12 months (2.09 years) for countries which comes under climatic zone I & II and 16.60 months (1.38 years) for countries which comes under climatic zone III & IV. Real time stability data of Rasayana Churna showed very good stability up to 1 year.

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