ACCELERATED STABILITY TESTING OF EXTEMPORANEOUS ORAL MORPHINE SOLUTION

ABSTRACT

Introduction: Stability studies are carried out to show evidence on how the quality of a drug product changes with time under a variety of environmental factors. Purpose: The purpose of this study was to carry out an accelerated stability studies on an extemporaneously prepared morphine sulphate using three exaggerated conditions of light. Method: The freshly prepared oral Morphine solution 5mg/ml were kept under these light conditions of sunlight, white bulb and Ultra Violet light for twelve weeks. Aliquot samples were withdrawn at specific time intervals and analyzed spectrophotometrically and a fourth sample was stored in the dark. Results: Extrapolation of the concentration versus time data showed that the concentration of oral morphine solution stored in the dark, by week 12 of the study had decreased to 0.2272mg/ml from the initial concentration of 1mg/ml. By week 12 of the study, the morphine concentration exposed to white fluorescence had decreased to 0.2880mg/ml from the initial concentration of 1mg/ml. This is equivalent to 28.80% decrease in the morphine concentration, by week 12 of the study, the morphine solution exposed to U.V Light had decreased to 0.2215mg/ml from the initial concentration of 1mg/ml. By week 12 of the study, the oral morphine concentration exposed to direct sunlight had decreased to 0.2161mg/ml from the initial concentration of 1mg/ml. Conclusion: This study confirmed that the concentration of extemporaneous oral morphine solution stored under sunlight had the lowest concentration of 21.61% remaining by week 12. This implied that morphine solution degrades faster under sunlight as against the other light conditions.