Accelerated Stability Study of Powder Formulation Safoof Muqliyasa and Safoof Mulayyin

Background and Objectives: Evaluation of stability studies of Unani Medicine (UM) formulations determined on the basis of scientific data are the need of the time and also recommended in D and C Act. There is immense need to evaluate precise shelf life for each powder formulations. Materials and Methods: Accelerated Stability Study (ASS) of Safoof Muqliyasa (S. Muq) and Safoof Mulayyin. (S. Mul) was carried out with at elevated temperature and humidity conditions 40ºC±2ºC with Relative Humidity of 75%±5% RH according to ICH guidelines, by keeping in stability chamber in containers used by commercial UM. Pharmacy’s (i.e. sealed HDPE containers). Testing frequency of samples was 0, 3 and 6 months and was subjected to various organoleptic, physical, microbiological and chemical tests parameters with HPLC quantification of active constituents/markers (Chebulic acid in S. Muq and Gingerol in S. Mul). Results were accessed as per API guidelines and are also statistically analyzed for 10% degradation, from liner regression equation using individual slope and Intercept. Results: Both S. Muq and S. Mul were suitable at accelerated condition upto 3 month storage on selected physical, microbiological and chemical parameters as per API evaluation guidelines, and it can be extrapolated that real time shelf life period (predicted stability) according to Grimm's statement, for zone III and IV, 3.3 as 10 month at room temperature and packaging method adopted in the study and by 10% degradation in different parameters by multiplying factor of 3.3 accelerated stability of Safoof Muqliyasa can be extrapoled as 2 years and 1 month and for Safoof Mulayyin 1 year and 5 months. Conclusion: According to physical and microbiological parameters both S. Muq and S. Mul are stable for 6 months in ASS but changes in selected chemical parameters was observed for after 3^rd month making it stable approximately for 1 year. Stability of salt containing S. Mul was found to be comparatively lower than the non-salt containing S. Muq This observation/ shelf life may be exclusive to both the powders.