HPLC法同时测定复方白氟膜剂中盐酸麻黄碱和地塞米松磷酸钠的含量

Simultaneous Determination of Ephedrine Hydrochloride and Dexamethasone Sodium Phosphate in Compound Baifu Pellicles by HPLC

目的:建立复方白氟膜剂中盐酸麻黄碱和地塞米松磷酸钠的含量测定方法。方法:以XTerra RP18色谱柱为分离柱,以甲醇-0.34%KH2PO4溶液-三乙胺(52∶48∶0.2)为流动相,采用HPLC法测定。结果:该品中盐酸麻黄碱含量测定线性范围为8.032~80.32μg.mL-1(r=0.999 9),平均回收率为99.25%(RSD=1.10%,n=6);地塞米松磷酸钠含量测定线性范围为3.984~39.84μg.mL-1,平均回收率为98.10%(RSD=1.32%,n=6)。结论:此法操作简单、结果准确,可用于复方白氟膜剂的质量控制。

Objective：To develop an HPLC method for the determination of ephedrine hydrochloride and dexamethasone sodium phosphate in Compound Baifu Pellicles.Methods： Analysis was conducted on a XTerra RP_（18） radial compression column with a mobile phase of methanol-0.34%KH_2PO_4 solution-triethylamine（52∶48∶0.2）.Results：The linear range of ephedrine hydrochloride was 8.032～80.32 μg·mL^（-1）（r=（0.999 9））,and the average recovery was 99.25%（RSD=1.10%,n=6）;The linear range of dexamethasone sodium phosphate was 3.984～39.84 μg·mL^（1）（r=（0.999 9））,and the average recovery was 98.10%（RSD=1.32%,n=6）.Conclusion：This method was simple and feasible for the quality control of Compound Baifu Pellicles.