Microwave Assisted Acclerated Stability Study of Metoprolo Tartrate In Sold State

Abstract

Stability studies are essential to confirm drug stability and quality till the time of ingestion by patients. Actual stability studies are long and therefore accelerated stability study are executed at high temperature and moisture condition to enhance the speed of reaction. Conferring towards the ‘International Conference on Harmonization (ICH)’ guidelines, accelerated stability studies are completed next to ‘40ºC ± 75%’ (RH) for around 6 months. Microwave-assisted heating has been used in chemistry for many years to enhance the speed of reaction which there by reduces the time for synthesis. The practice of using a microwave to perform accelerated stability studies instead of the conventional method might diminish the time for calculating the constancy of the treatment ingredient. However, there remains a lack of any substantial evidence about the use of microwave-assisted stability studies in the literature. Hence, the goal of work being done was to assess the possibility of the microwave assisted heating method in the estimation of drug stability. In this project, an effort was made to work out accelerated stability study of Metoprolol tartrate using microwave heating and conventional method. Degradation from both the methods were analyzed to compare the results. The Metoprolol tartrate sample were kept in the stability chamber at 40ºC ± 75 % RH and were collected at different time intervals. Correspondingly, samples were also kept in microwave at different conditions having power range from 200W - 600W; temperature range from 80 ˚C - 100 ˚C and water level from 50μl to80 μl. The degradation behavior was analyzed by the aid of HPLC (High-performance liquid chromatography).The chromatograms obtained from microwave-assisted method were compared with the conventional method. The study confirmed a substantial correlation between conventional and microwaveassisted stability. The microwave-assisted stability study under conditions with (80μL water; 600W; 100T; 30min) showed no degradation product in mixture with PVP K30 to that compared the conventional method. Therefore, to conclude microwave-assisted heating is an efficient way to perform the accelerated stability study of APIs.