Reproducibility Study of the Efficiency of Coating on Preventing Photolytic Degradation of Presonil® (Metoprolol Tartrate) Tablets

Abstract

This work was aimed for the determination of photolytic degradation of Presonil® (metoprolol tartrate). It was also done to determine the reproducibility of results of the previous research project on photolytic degradation of metoprolol tartrate in various lighting conditions (control, sunlight, normal room light, 25watt & 40watt bulb). A group of tablets were kept in dark as control to compare the results. Besides, physical tests were performed for evaluation of color change, weight variation, thickness and hardness of Presonil® tablets from same batch according to the specification of USP. A very insignificant fluctuation in result was observed, with standard deviation ±0.0007%, ±0.02% & ±0.013% for weight variation, hardness & thickness test respectively. But in various lighting condition like 25watt bulb, 40watt bulb, direct sunlight and normal room light the concentration of metoprolol tartrate were decreased gradually with percent deviation 10.41%, 11.24%, 6.99% and 13.25% respectively. So it can be suggest that the Presonil® containing metoprolol tartrate is light sensitive and coating alone is not sufficient to protect the drug from light. So that package should be opaque thus light cannot pass through the package.