HPLC法同时测定钙泊三醇/倍他米松软膏中2种主药的含量

目的:建立同时测定钙泊三醇/倍他米松软膏中2种主药含量的方法。方法:采用高效液相色谱法。色谱柱为Intersil C18,流动相为甲醇-乙腈-磷酸盐缓冲液(pH6.0)=58∶22∶20,检测波长为265nm,柱温为25℃,流速为1.0mL·min-1。结果:钙泊三醇与倍他米松可完全分离,二者检测浓度线性范围分别为1.25～3.75、12.5～37.5μg·mL-1(r=0.9999、0.9990),平均加样回收率分别为100.4%(RSD=0.75%,n=9)和100.8%(RSD=0.63%,n=9)。结论:该方法灵敏、精密度高、回收率好,可用于该制剂的含量测定。

Simultaneous Determination of 2 Kinds of Main Components in Calcipotriol/Betamethasone Ointment by HPLC

OBJECTIVE：To establish a method for the simultaneous determination of 2 kinds of main components in Calcipotriol/betamethasone ointment.METHODS：HPLC was adopted.Intersil C18 column was used with methanol-acetonitrile-phosphate buffer（pH 6.0）（58 ∶ 22 ∶ 20） as mobile phase at flow rate of 1.0 mL·min-1.The detection wavelength was set at 265 nm.The column temperature was set at 25 ℃.RESULTS：Calcipotriol and betamethasone could be separated completely.The linear range was 1.25～3.75 μg·mL-1 for calcipotriol（r=0.999 9） and 12.5～37.5 μg·mL-1 for betamethasone（r=0.999 0） .The average recoveries of calcipotriol and betamethasone were 100.4%（RSD=0.75%,n=9） and 100.8%（RSD=0.63%,n=9） .CONCLUSION：The method is sensitive,accurate and reproducible for the content determination of Calcipotriol/betamethasone ointment.