倍氯米松尿素乳膏中丙酸倍氯米松的含量测定

Determination of the content of beclometasone dipropionate in Beclometasone Dipropionate and Urea Cream

目的建立高效液相色谱法测定倍氯米松尿素乳膏中丙酸倍氯米松含量的方法。方法色谱柱(菲罗门C184.6 mm×150 mm,4μm),以甲醇-水(82∶18)为流动相,流速1.0 mL/min,检测波长240 nm。结果线性范围(0.94～4.72)μg/mL(r=0.999 99),高、中、低浓度的平均回收率分别为101.46%、101.35%、101.57%,RSD分别为0.29%、0.17%、0.77%。结论该法分离度好、快速、简便、重现性好,可用于倍氯米松尿素乳膏的质量控制。

Objective To develop a HPLC method for determination of the content of beclometasone dipropionate in Be- clometasone Dipropionate and Urea Cream. Methods A Phenomenex Synergi C18 column （4.6 mm×150 mm, 4 μm） was used with a mobile phase of methanol-water （82：18）. The detection wave-length was 240 nm. The flow rate was 1.0 mL/min. Re- sults The linear range was （0.94-4.72） μg/mL （r = 0.999 99）. The average recoveries of high, medium and low concentrations were 101.46% （RSD=0.29%）, 101.35% （RSD=O.17%） and 101.57% （RSD=0.77%）. Conclusion The method is simple, ac- curate, and has good reproducibility and can be used in quality control of beclometasone dipropionate in Beclometasone Dipropionate and Urea Cream.