Accelerated stability studies of Sufoofe Sailan: A Unani formulation.

Abstract

Introduction:Sufoofe Sailan (SS) is a polyherbal powder preparation used in Unani medicine to treat gynecological diseases. It is observed that SS degrade early as it is in the form of powder; however, the stability study of SS was not carried out till date.Aim:To evaluate the accelerated stability of SS.Materials and Methods:Finished formulation of SS was packed in three airtight transparent polyethylene terephthalate containers. One pack was analyzed just after manufacturing and remaining two packs were kept in stability chamber at 40°C ± 2°C/75% ± 5% RH, of which one pack was analyzed after the completion of three and another after 6 months. Organoleptic, physico-chemical, microbiological parameters along with high-performance thin layer chromatography (HPTLC) fingerprinting were carried out.Results:Organoleptic characters showed no significant change in accelerated stability condition. All physico-chemical parameters showed changes <5%, HPTLC fingerprinting showed minimum changes and microbial studies were in confirmation to the World Health Organization guidelines.Conclusion:SS confirmed to the International Conference on Harmonization Guideline for accelerated testing of the pharmaceutical product on said parameters and as per the Grimm's statement the shelf life of SS may last 20 months.