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目的建立HPLC法测定无极膏中丙酸倍氯米松的含量,并确定其含量限度。方法Dia-monsil C18柱(4.6 mm×250 mm,5μm);流动相:甲醇-水(70∶30);流速:1.0 ml/min;检测波长为240 nm。结果丙酸倍氯米松的线性范围为2.14~19.24μg/ml,r=0.9995。样品平均回收率为100.2%,RSD为1.1%。结论本法简单,快速,结果准确,可有效控制该制剂中丙酸倍氯米松的含量。
OBJECTIVE To establish an HPLC method for the determination of beclomethasone dipropionate in the cream and determine its content limit. Methods Dia-monsil C18 column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase was methanol-water (70:30). The flow rate was 1.0 ml / min. The detection wavelength was 240 nm. Results The linear range of beclomethasone dipropionate was 2.14 ~ 19.24μg / ml, r = 0.9995. The average recovery of samples was 100.2% with a RSD of 1.1%. Conclusion This method is simple, rapid and accurate. It can effectively control the content of beclomethasone propionate in the preparation.