Reverse phase liquid chromatographic determination of dexamethasone acetate and cortisone acetate in bulk drug substances and dosage forms: method development.

The determination of the steroid acetates was evaluated for ruggedness of the method by using an octyldecylsilane column, 254 nm detection, and acetonitrile-water as mobile phase. Mobile phase pH, oven temperature, and columns from various manufacturers had no dramatic effect on the chromatography. The method was then optimized for dexamethasone acetate and cortisone acetate bulk drug and dosage forms. For dexamethasone acetate, the bulk drug substance should be dried at 105 degrees C before use, and the sample should be dissolved in 50% acetonitrile-buffer pH 6 for stability. Cortisone acetate, on the other hand, was found to be nonhygroscopic and hence could be used as received. For stability, the sample should be stored in 50% acetonitrile-buffer pH 4.