Stability Study Of Aspirin Tablet In Crush Condition Stored In Glass And Plastic Container By Using The Reverse Phase High Performance Liquid Chromatography.

Abstract

The objective of the present to research work is to provide the detailed analytical stability study of anti-inflammatory drug product i.e. Aspirin on its different physical condition as well as different storage container. Different condition i.e. crush condition in which the surface area of drug product increased and it can lead to increase the impurity levels of drug product. And by using the different storage container, compatibility of packaging materials can be evaluated. Aspirin is available in the form of tablet with aluminium wrapped blister pack. In this study, tablets were crushed and stored in wide mouth plastic container which kept in different stability stations (30°C/65%RH and 40°C/75%RH). The forced degradation study performed in acidic, alkali, oxidative, thermal and photolytic conditions to check its degradation impurity profile. Alkali degradation shows more than 50% degradation of Aspirin drug substance. The samples kept in plastic container at different stability time points were analysed by using the Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) as per Indian Pharmacopeia (IP). Based on the analytical data, the Assay of tablet found more than 95.0% while related impurities were found less than 1.0% as per specification of Indian Pharmacopeia. The data shows the molecule stability in crush condition and null impact of packaging material on crushed tablets.