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目的建立测定倍他米松尿素乳膏中倍他米松和羟苯乙酯含量的方法。方法色谱柱:PLATISILTMODS(250 mm×4.6 mm,5μm),流动相:乙腈-水(30∶70),检测波长:240 nm,流速:1.0 ml·min-1,柱温:45℃。结果倍他米松、羟苯乙酯分别在3.94~23.64μg·ml-1(r=0.9999)、4.78~28.68μg·ml-1(r=1.0000)范围内线性关系良好;回收率、RSD分别为倍他米松99.7%、0.92%,羟苯乙酯100.4%、0.40%。结论本方法简便、准确、重复性好,可用于该制剂中倍他米松和羟苯乙酯的含量测定。
Objective To establish a method for the determination of betamethasone and hydroxypropiophenol in the betamethasone urea cream. Methods Column: PLATISILTMODS (250 mm × 4.6 mm, 5 μm), mobile phase of acetonitrile-water (30:70), detection wavelength of 240 nm, flow rate of 1.0 ml · min-1 and column temperature of 45 ℃. Results Betamethasone and hydroxyphenylethyl ester showed good linearity in the range of 3.94 ~ 23.64μg · ml-1 (r = 0.9999) and 4.78-28.68μg · ml-1 (r = 1.0000) respectively. The recovery and RSD were Betamethasone 99.7%, 0.92%, 100.4%, 0.40%. Conclusion The method is simple, accurate and reproducible. It can be used for the determination of betamethasone and p-hydroxybenzoate in this preparation.