中国临床药学杂志

目的建立HPLC法同时测定丙酸氯倍他索硝酸咪康唑搽剂中丙酸氯倍他索和硝酸咪康唑的含量。方法流动相为甲醇-0.35%磷酸溶液(三乙胺调节pH值至3.3±0.2)=70∶30(V/V),流速1.0 mL.min-1,Kromasil C18色谱柱,检测波长240nm。结果丙酸氯倍他索的线性范围为12~28 mg.L-1,r=0.999 2,回收率100.2%,RSD=0.80%;硝酸咪康唑的线性范围为240~560 mg.L-1,r=0.999 6,回收率99.91%,RSD=0.75%。结论该方法简便、快速和准确,适用于该搽剂的质量控制。

AIM To determine clobetasol propionate and miconazole nitrate in clobetasol propionate/miconazole nitrate for leniment simultaneously by HPLC.METHODS The determination was performed on kromasil C18 column.The mobile phase consisted of methanol-0.35% phosphate(adjusting pH to 3.3±0.2 with triethylamine)=70∶30(V/V) with a flow rate of 1.0 mL·min-1.The detective wavelength was set at 240 nm.RESULTS The linear range of clobetasol propionate was 12-28 mg·L-1(r=0.999 2) and recovery rate was 100.2%(RSD=0.80%);the linear range of miconazole nitrate was 240-560 mg·L1(r=0.999 6),recovery rate was 99.91%(RSD=0.75%).CONCLUSION The method is simply,rapid and accurate,and suitable for the quality control of clobetasol propionate/miconazole nitrate for liniment.