Shaw M C, Vanderwielen A J
J Pharm Sci. 1984 Nov;73(11):1606-8. doi: 10.1002/jps.2600731130.
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.
描述了一种用于定量乳膏和软膏制剂以及原料药中醋酸双氟拉松（I）的高效液相色谱法。醋酸异氟泼尼龙（II）用作内标，使用3微米硅胶柱，流动相由水饱和的丁基氯-水饱和的二氯甲烷-四氢呋喃-乙酸（350:125:10:15）组成，实现了有效分离。该方法对四种制剂（两种乳膏和两种软膏）以及原料药给出了准确结果。该测定法对乳膏制剂的相对标准偏差约为1.8%，对软膏制剂为1.3%，对原料药为1.0%。该方法对I具有特异性，能够分离结构相关的化合物。
