鼻可灵喷雾剂中地塞米松磷酸钠、氧氟沙星及盐酸麻黄碱含量的微乳液相色谱法测定

Determination of Dexamethasone Sodium Phosphate,Ofloxacin and Ephedrine Hydrochloride in BiKeling Nasal Spray by Microemulsion Liquid Chromatography

建立了复方鼻可灵喷雾剂中3组分的微乳液相色谱（MELC）测定方法，并考察了其影响因素。以微乳（33g／L SDS-1．2％（体积分数）正辛烷-9％（体积分数）正丁醇-0．5％（体积分数）三乙胺，磷酸调pH至3）为流动相，采用Hypersil BDS C18 5μm（4．6mm×150mm）色谱柱，检测波长256nm。实验发现，被测组分地塞米松磷酸钠、氧氟沙星及盐酸麻黄碱的线性范围和相关系数分别为0．01～0．04g／L，r=0．9999；0．1～0．3g／L，r=0．9999；0．2～0．6g／L，r=0．9999。对应的平均回收率和RSD（n=5）分别为97％，2．55％；101％．0．45％；101％，0．54％（n=5）。

A method for the determination of dexamethasone sodium phosphate, ofloxacin, ephedrine hydroehloride in BiKeling nasal spray by microemulsion liquid chromatography （MELC） was established and its influential factors were discussed. The analytical column was Hypersil BDS C18 5 μm （4. 6 mm × 150 mm）, with column temperature of 30 ℃. The mobile phase was microemulsion consisting of 33 g/L SDS, 9% （by volume） butanol, 1.2% （by volume） octane and 0. 5% TEA（by volume）, adjusting pH = 3 with phosphate acid, flow rate was 1.0 mL/min and detection wavelength was 256 nm. The calibration curves were linear in the ranges of 0.01 - 0.04 g/L for dexamethasone sodium phosphate, 0.1 -0.3 g/L for ofloxacin and 0.2 -0.6 g/L for ephedrine hydrochloride with r =0. 999 9. The average recoveries and RSD were 97% and 2.55% , 101% and 0.45% , 101% and 0. 54% , respectively.