Stability Profiling of Gokshuradi Kashaya under Accelerated Conditions: An Analytical Study

Background

Gokshuradi Kashaya is a classical formulation mentioned in Sahasrayoga, which is widely used for its therapeutic benefits. Traditionally, the saviryata avadhi of Kashaya is considered to be less i.e. 24 hr, but modern pharmaceutical practices makes it necessary for a scientific evaluation of its stability.

Objectives

To identify the stability of Gokshuradi kashaya by using accelerated stability study method.

Materials and Methods

Gokshuradi Kashaya was prepared as per the standard classical procedure. Samples were stored under accelerated conditions (40±2ºC and 75±5% RH) for 6 months as per ICH Q1A (R2) guidelines. Stability study had 3 timepoints for assessments i.e. 0^th month, 3^rd month and 6 months. Parameters like organoleptic characters and microbial load and TLC profile was been assessed.

Results

There was no significant changes observed in organoleptic characters. Slight reductions in pH and minor variations in total solids and viscosity were present but within acceptable limits. Microbial load showed reduced bacterial load and no fungal contamination during 6 months. There was no change observed in TLC profiles.

Conclusion

Gokshuradi Kashaya was found to be stable in physicochemical, microbial load. These findings can provide a provisional shelf life of six months, it needs to be confirmed by long-term real-time stability studies.