Stability of ketorolac tromethamine in 5% dextrose injection and 0.9% sodium chloride injections

The stability of ketorolac tromethamine in 5% dextrose injection and 0.9% sodium cholride injection has been studied using a stability-indicating, high-performance liquid chromatography assay method developed in our laboratory. This method is precise and accurate, with a percent relative standard deviation of 0.85% based on five readings. The admixtures were stable for at least 50 days when stored at 5 deg C. At 25 deg C the 0.9% sodium chloride admixture was stable for at least 35 days, and in 5% dextrose injection for only seven days. After 14 days of storage at 25 deg C the pH value of the admixture in 5% dextrose injection had decreased from 6.6 to 4.3. The changes in pH values of all other admixtures were less than 0.55. This assay method can be used to quantify ketorolac tromethamine in injections and tablets.