Abstract
Stability studies provide evidence on in what way the quality of a drug or its product varies with time under influence of changing environmental factors such as humidity, temperature and light. Present study is an attempt to study accelerated stability of fish oil incorporated with three medicinal plant extracts, which can be used for preserving it from further oxidation. The results of accelerated shelf life studies of fish oil treated with O. sanctum extracts (2 mg%). It is found that E. coli, Salmonella and P. aeruginosa were absent throughout the storage period of 6 months in the treated sample. Though TPC was found high at initial stage (1250000 cfu/gm.), by 6 months the value was reduced to <05 cfu/gm. Fungus and yeast contents with a high value during 2nd month (1000 cfu/gm) decreased to a value of 110 cfu/gm in 6 months. Rancidity index showed absent in all the days. Contrary to O. sanctum treated fish oil, the total fungus and yeast content which was minimum at the initial period (<10 cfu/ml) increased to a maximum value of 2110 cfu/gm in A. barbadensis and B. diffusa treated samples. Rancidty was absent throughout the storage period in both the treatments. Thus total fungus and yeast content was significantly lowered in O. sanctum treated fish oil when compared with A. barbadensis and B. diffusa treated fish oil.
Highlights
India is considered as a gold mine of traditional medicinal plants with an established record and people have a good knowledge of its use
It is proved that the stability study is unavoidable for the assessment of product quality
Pharmaceutical products are studied for its stability profile in an accelerated humidity and temperature, and these investigational findings can be very helpful for predicting reliable expiry date or shelf-life at room temperature by assuming certain criteria and assumptions [1]
Summary
India is considered as a gold mine of traditional medicinal plants with an established record and people have a good knowledge of its use. It is difficult for the manufacturer to wait till the drug degrades naturally to about 90% of labeled amount at room temperature Taking this into account the stability study is normally supported for assigning shelf-life of any drugs. A series of guidelines which are acceptable to multiple countries for the approval of a drug have been established and known as Quality Guidelines or ICH (International Council for Harmonization of technical requirements for pharmaceutical for Human use) guidelines. By using this method we can predict the shelf life of any drug product in a very short period of time
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