HPLC梯度洗脱法同时测定地麻滴鼻液中2种组分的含量

Simultaneous determination of two components in dexamethasone-ephedrine nasal drops by HPLC gradient elution

目的建立测定地麻滴鼻液中地塞米松磷酸钠和盐酸麻黄碱的高效液相色谱法。方法色谱柱为Agilent ZORBAX SB-C18柱（150 mm×4.6 mm,5μm）,流动相为磷酸二氢钾缓冲液-甲醇-乙腈,梯度洗脱,流速1 m L/min,检测波长242 nm。结果地塞米松磷酸钠在5.2～52.0μg/m L范围内线性关系良好（r=0.999 9）,盐酸麻黄碱在0.501～5.01 mg/m L范围内线性关系良好（r=0.999 5）。地塞米松磷酸钠平均回收率为99.13%,RSD为1.46%;盐酸麻黄碱平均回收率为99.19%,RSD为1.04%。结论该法简便、准确并且重现性好,可用于地麻滴鼻液中地塞米松磷酸钠和盐酸麻黄碱的质量控制。

Objective To establish an HPLC method for the simultaneous determination of dexamethasone sodium phosphate and ephedrine hydrochloride in dexamethasone-ephedrine nasal drops.Methods The Agilent ZORBAX SB-C_（18） column（150 mm × 4.6 mm,5 μm） was used.The mobile phase was composed of gradient potassium dihydrogen phosphate solution-methanol-acetonitrile at the flow rate of 1.0 mL/min.The UV detection wavelength was242 nm.Results The linear ranges for dexamethasone sodium phosphate and ephedrine hydrochloride were respectively 5.2 ～52.0 μg/mL（r =0.999 9） and 0.501 ～5.01 mg/mL（r = 0.999 5）.The mean recoveries of them were respectively 99.13%and 99.19%with the RSD at 1.46%and 1.04%.Conclusion This method is simple,accurate and reliable,and can be used for the quality control of dexamethasone-ephedrine nasal drops.