HPLC法测定复方硝酸咪康唑乳膏的含量

目的：建立高效液相法测定复方硝酸咪康唑乳膏中硝酸咪康唑和醋酸曲安奈德的含量。方法：色谱柱为Hypersil BDS C18柱（250mm×4．6mm，5μm），流动相为三乙胺溶液（10ml三乙胺加水至1000ml，用磷酸调节pH至2．5）-甲醇-乙腈-四氢呋喃（7：5：4：3），流速为1ml·min^-1，检测波长为227nm，进样量为20μl。结果：硝酸咪康唑在进样量735．0～24．5μg，醋酸曲安奈德在进样量100．0～2．5μg范围内线性关系良好（r分别为0．9999和0．9999），平均回收率分别为100．8％（RSD=1．1％）和100．5％（RSD=1．3％）。结论：本方法简便、准确，重复性好，可用于复方硝酸咪康唑乳膏的含量测定和质量控制。

Determination of Compound Miconazole Nitrate Cream by HPLC

Objective： To determine the contents of miconazole nitrate and triamcinolone acetonide in compound miconazole nitrate cream by HPLC. Method： The Hypersil BDS C18 （250 mm ×4.6 mm,5 μm） was used ,the triethylamine soiution（ 10 ml of triethylamine diluted to 1 000 ml with water, and adjust pH to 2.5 with phosphoric acid）-methanol-acetonirile-tetrahydrofuran（7： 5： 4：3 ） as the mobile phse, the detection wavelength was 227 nm and the flow rate was 1.0 ml · min ^- 1, the amount of injection was 20 μl. Result ： There were good linearity between peak areas and injection quantity of miconazole nitrate within the range of 735.0 - 24.5 μg （ r = 0.999 9 ） and triamcinolone acetonide within the range of 100.0 - 2.5 μg（ r = 0. 999 9）. The average recovery was 100.8% for miconazole nitrate （ RSD = 1.1% ） and 100.5 % for triamcinolone acetonide （ RSD = 1.3 % ）. Conclusion ： The method is simple , accurate, sensible and reproducible, which can be used for the determination both the raw material and preparations and the quality control of compound miconazole nitrate cream.