Liquid chromatographic assay for diflorasone diacetate in cream and ointment formulations

A high-performance liquid chromatographic assay for quantitating diflorasone diacetate (I) in cream and ointment formulations and in bulk form is described. Isoflupredone acetate (II) was used as the internal standard and a 3-micron silica gel column with a mobile phase comprised of water-saturated...

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Bibliographic Details
Published inJournal of pharmaceutical sciences Vol. 73; no. 11; p. 1606
Main Authors Shaw, M C, Vanderwielen, A J
Format Journal Article
LanguageEnglish
Published United States 01.11.1984
Subjects
Betamethasone - analogs & derivatives
Betamethasone - analysis
Chemical Phenomena
Chemistry
Chromatography, High Pressure Liquid - methods
Ointments
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Summary:A high-performance liquid chromatographic assay for quantitating diflorasone diacetate (I) in cream and ointment formulations and in bulk form is described. Isoflupredone acetate (II) was used as the internal standard and a 3-micron silica gel column with a mobile phase comprised of water-saturated butyl chloride-water-saturated methylene chloride-tetrahydrofuran-acetic acid (350:125:10:15) led to an efficient separation. The method gave accurate results for four formulations, two creams and two ointments, as well as the bulk drug. The assay has an RSD of approximately 1.8% for the cream formulations, 1.3% for the ointment formulations, and 1.0% for the bulk drug. The method is specific for I and capable of resolving structurally related compounds.
ISSN:0022-3549
DOI:10.1002/jps.2600731130