HPLC法同时测定复方克霉唑乳膏中2种成分的含量

Simultaneous determination of two components in compound clotrimazole cream by HPLC

目的建立高效液相色谱法测定复方克霉唑乳膏中克霉唑和丙酸氯倍他索的含量。方法以0.05 mol/mL磷酸二氢钾溶液(10%磷酸调节pH值至3.8)-甲醇-乙二胺(25∶75∶0.2)为流动相,采用伊利特Hy-persil BDS-C18(150 mm×4.6 mm,5μm)色谱柱,流速为0.8 mL/min,检测波长为240 nm,柱温为30℃,进样量20μL。结果克霉唑和丙酸氯倍他索分别在90.0～720.0μg/mL(r=0.999 8)和1.38～11.0μg/mL(r=0.999 9)范围内线性关系良好,平均回收率分别为96.6%和98.5%,RSD均为1.7%。结论本法操作简便,结果准确,精密度高,可以同时测定复方克霉唑乳膏中克霉唑和丙酸氯倍他索的含量,可用于乳膏制剂的质量控制。

Objective To establish an HPLC method for determination of clotrirnazole and clobetasol propio- nate in compound clotrimazole cream. Methods The analytical column was Hypersil BDS-C18 （ 150 mm× 4. 6 mm, 5 μm）, with a mobile phase consisted of 0. 05 mol/L potassium＇dihydrogen phosphate solution （ 10% phosphoric acid so- lution with pH adjusted to 3.8 ）, methanol and ethanediamine （ 25： 75： 0. 2 ） at the flow rate of 0. 8 mL/min. Detection wavelength was set at 240 nm, and the column temperature was 30 ℃, and the injection volume was 20 μL. Results The linear range of clotrimazole and clobetasol propionate was 90. 0 - 720.0 μg/mL （ r = 0. 999 8 ） and 1.38 - 11.0 μg/mL（r = 0.999 9）respectively, and the average recovery rate was 96. 6% （RSD = 1.7% ）and 98.5% （RSD = 1.7% ） respectively. Conclusion The method is convenient, accurate with high precision, and it can be used in the content determination of clotrimazole and clobetasol propionate in compound clotrimazole cream at the same time, and can be used for the quality control of the cream.