HPLC-ELSD法测定曲咪新乳膏中硫酸新霉素和硝酸咪康唑的含量

Determination of Neomycin Sulfate and Miconazole Nitrate in Compound Cream by HPLC-ELSD

目的:建立HPLC-ELSD法测定曲咪新乳膏中硫酸新霉素和硝酸咪康唑的含量。方法:采用Aglient Eclipse Plus C_(18)柱(250 mm×4.6 mm,5μm);以0.1%的三氟乙酸溶液为流动相A,以乙腈为流动相B,梯度洗脱;流速为1.0 mL·min^(-1);蒸发温度为40℃;雾化温度为40℃;氮气载气流速为1.8 L·min^(-1)。结果:硫酸新霉素和硝酸咪康唑分别在140.41~702.07 U·mL^(-1)、484~2420μg·mL^(-1)范围内峰面积的对数与质量浓度的对数呈现良好的线性关系(r分别为0.9996、0.9992);平均回收率分别为99.0%、99.1%;RSD分别为0.81%、0.76%。结论:该方法简便、快速、准确并且重现性好。

Objective： To establish a method for the determination of neomycin sulfate and miconazole nitrate in the Triamcinolone Acetonide Acetate and Miconazole Nitrate and Neomycin Sulfate Cream by HPLC-ELSD. Methods： The separation was carried out on an Aglient Eclipse Plus C18 column （250 mm×4.6 mm, 5 μm） column with a mobile phase of 0.1% trifluoro acetic acid （A） and acetonitrile （B） in gradient, at a flow rate of 1.0mL·min-1; the evaporation temperature was 40; the atomization temperature was 40℃; the flow rate of carrier gas was at 1.8 L·min-1. Results： The logarithm of the contents of neomycin sulfate had good linear relationship with the logarithm of their peak areas in the scope of 140.41-702.07 U·mL-1（r=0.9996）, and the logarithm of the contents of miconazole nitrate had good linear relationship with the logarithm of their peak areas in the scope of 484-2420μg·mL-1 （r=0.9992）; the average recoveries were 98.9% and 99.1% （RSD=0.84% and 0.76%）, respectively. Conclusion： The method is simple, rapid, accurate and has excellent precision.