Abstract

EVALUATION OF THE SHELF LIFE PERIOD OF A SIDDHA FORMULATION, NILAPPANAI CHOORANAM

S. Selvarajan, V. Gayathri Devi*, R. Rejani and Anitha John

Abstract

Stability or shelf life period is an important matter regarding ASU - Ayurveda, Siddha, Unani - formulations. Stability is the capability of a specific formulation in a particular container/ closure system to remain within its physical, chemical, microbiological, toxicological and therapeutic specifications. The objective of the present study was to evaluate stability study of a Siddha compound formulation, Nilappanai chooranam. Accelerated stability study was carried out at a temperature 40°C ± 2 and Relative Humidity (RH) 75% ± 5 and real time stability study at temperature 30°C ± 2 and RH 60% ± 5. The change in organoleptic parameters, physico-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 the actual degradation rate of Nilappanai chooranam with respect to accelerated condition. No change was observed in color, odour and taste of the chooranam 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 the chooranam was calculated with 10% degradation rate from physico-chemical parameters at accelerated condition, 40°C ± 2 and 75% ± 5 RH. The present study supports that the chooranam was suitable at accelerated condition up to 6 month storage. It was observed that the shelf life of chooranam is observed as 1.99 yrs for countries which comes under climatic zone I & II and 1.31 years for countries which comes under climatic zone III & IV. Real time stability data showed very good stability up to 1 year.

Keywords: Nilappanai chooranam, physico-chemical parameters, shelf life period, microbial contamination, stability study.