Reverse-phase liquid chromatographic determination of dexamethasone acetate and cortisone acetate in bulk drug substance and dosage forms: collaborative study.
A reverse-phase liquid chromatographic method for determination of dexamethasone acetate and of cortisone acetate was subjected to an interlaboratory study by 8 collaborators for each steroid acetate. Bulk drug substance, suspensions, and tablets were assayed. Bulk drug or dosage form is dissolved in an acetonitrile-buffer mixture and analyzed by an external standard method. The steroid acetate is resolved from extraneous components by reverse-phase chromatography and detected at 254 nm. The sample solutions are stable for at least 72 h. For dexamethasone acetate, coefficients of variation were 0.9 and less than or equal to 3.1% for the bulk drug substance and the suspensions, respectively. For cortisone acetate, coefficients of variation were 0.7% for bulk material, less than or equal to 2.0% for suspensions, and less than or equal to 2.5% for tablets. All dosage forms were commercial formulations. The 2 methods have been adopted official first action.
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Merck Sharp and Dohme, Research Laboratories, West Point, PA 19486.
D002853:Chromatography, Liquid; D003348:Cortisone / Q000031:analogs & derivatives* / Q000032:analysis; D003907:Dexamethasone / Q000031:analogs & derivatives* / Q000032:analysis; D007202:Indicators and Reagents; D013535:Suspensions; D013607:Tablets
D007202:Indicators and Reagents; D013535:Suspensions; D013607:Tablets; D003907:Dexamethasone; C018038:dexamethasone acetate; D003348:Cortisone