复方倍他米松搽剂中倍他米松含量的测定

HPLC Determination of Betamethasone in Compound Betamethasone liniment

目的：建立完善的高效液相色谱法,准确地测定复方倍他米松搽剂中倍他米松的含量。方法：采用Waters Symmetry C18（250 mm×4.6 mm,5μm）色谱柱,流动相为乙腈-水（25：75）,流速：1.0mL/min,柱温35℃,检测波长240nm。结果：倍他米松的线性范围为10～100μg/mL（r=0.9999）；平均加样回收率为101.8%,RSD为1.3%（n=9）。结论：该方法简便准确,为该制剂的质量控制提供可靠依据。

Objective： To establish an improved HPLC method for the accurate determination of betamethasone in compound betamethasone liniment. Methods： The chromatographic separation was performed on a Waters Symmetry C18 column with a mixture of acetonitrile and water（25：75 v/v）as mobile phase at the flow rate of 1.0mL/min. The column temperature was maintained at 35℃ and the detection wave length was 240 nm. Results： The calibration curves in the range of 10-100 μg/mL（r=0.9999） for betamethasone was linear. The average recovery was 101.8%, and RSD was 1.3%（n=9）. Conclusion： An accurate method can be used for the quality control of compound betamethasone liniment.