高效液相色谱法测定麻氟滴鼻液中两组分的含量

目的建立测定麻氟滴鼻液中盐酸麻黄碱和地塞米松磷酸钠含量的方法。方法采用高效液相色谱（HPLC）法，色谱柱为Hypersil BDS C18柱（250mm×4．6mm，5μm），流动相为0.025mol／L磷酸二氢钾（加入0．5％三乙胺，用磷酸调节pH值至3．5）-甲醇-乙腈（52：38．4：9．6），流速为0．9mL／min，检测波长为257nm，柱温为40℃。结果盐酸麻黄碱质量浓度在100～600μg／mL范围内与峰面积线性关系良好（r=0．9998），平均回收率为100．54％，RSD=1．0％（n=6）；地塞米松磷酸钠质量浓度在10～60μg／mL范围内与峰面积线性关系良好（r=0．9998），平均回收率为100．20％，RSD=1．2％（n=6）。结论HPLC法专属性好，操作简便、快速，结果准确，可用于麻氟滴鼻液的质量控制。

Determination of Ephedrine Hydrochloride and Dexamethasone Sodium Phosphate in Mafu Nasal Drops by HPLC

Objective To establish a method for the content determination of ephedrine hydrochloride and dexamethasone sodium phosphate in Mafu Nasal Drops by high performance liquid chromatography （HPLC）.Methods The HPLC method was used. The analytical column was Hypersil BDS C18 column （250 mm ×4.6 mm, 5 μm） with the column temperature of 40℃, the mobile phase consisted of 0.025 mol/L KH2PO4 solution （added 0. 5% of triethylamine, and adjusted pH value to 3.5 with phosphoric acid）-methanol- acetonitrile （52：38.4： 9.6）, the detecting-wavelength was 257 nm and the flow rate was 0. 9 mL/min. Results The linear range of ephedrine hydrochloride was 100-600 μg/mL, r=0.999 8. The average recovery rate was 100.54% （RSD=1.0%, n=6）; the linear range of dexamethasone sodium phosphate was 10-60 μg/mL, r =0. 999 8. The average recovery rate was 100. 20% （RSD = 1.2%, n =6）. Conclusion The method is simple, rapid and specific with accurate and reliable results, which can be used for the quality control of Mafu Nasal Drops.