Chemical Stabilities of Hydrocortisone in an Oral Liquid Dosage Form without Suspending Agents

The chemical stability of hydrocortisone in an oral liquid dosage form without suspending agents was studied by using a stability-indicating high-performance liquid chromatographic assay method that was developed in our laboratory. The concentrations of the drug (range tested, 12 to 22 micrograms/mL) were related directly to peak heights and the percent relative standard deviation based on five injections was 0.8. The products of decomposition and excipients present in the dosage forms did not interfere with the developed assay method. The developed dosage form was almost uniform, with an intraday percent relative standard deviation based on five injections of 2.5, and the 5-day interday percent relative standard deviation was 2.8. The mixture was stable for at least 60 days when stored in amber-colored glass bottles at room temperature. The pH value of the mixture remained constant at 4.6 after 60 days of storage, and the physical appearance of the formulation did not change during the study period.