梯度洗脱HPLC法同时测定高原康胶囊中三组分的含量

Simultaneous Determination of Aminophylline Dexamethasone Sodium Phosphate and Diazepam in Gaoyuankang Capsules by Gradient Elution HPLC Method

目的建立梯度洗脱法同时测定高原康胶囊中氨茶碱、地塞米松磷酸钠、地西泮3组分含量的简便方法。方法采用Athena C18-WP(5μm,100A4.6 mm×250 mm Serial No.0AG72U42)色谱柱;0.05 mol/L磷酸二氢钠溶液为流动相A,甲醇为流动相B,梯度洗脱;检测波长为240 nm;流速:1.0 ml/min。结果氨茶碱、地塞米松磷酸钠、地西泮线性范围分别为400.03～2800.2μg/ml;5.998～20.993μg/ml;10.008～75.06μg/ml,r=0.9999。平均回收率分别为99.58%、99.97%、99.74%。结论本法快速、简便,可用于该制剂中3种成分的同时测定。

Objective To establish a gradient elution HPLC method for determining three constituents of Gaoyuankang capsules：aminophylline,dexamethasone sodium phosphate and diazepam.Methods Athena C18-WP（5 μm,100 4.6 mm × 250 mm Serial No.0AG72U42） column was used.The mobile phase consisted of 0.05 mol/L sodium dihydrogen phosphate solution as mobile phase A and methanol as mobile phase B.Gradient elution was used.The detection wavelength was 240 nm and the flow rate was 1.0 ml/min.Results The linear response ranged from 400.03 to 2800.2 μg/ml for aminophylline（r=0.9999）,5.998 to 20.993 μg/ml for dexamethasone sodium phosphate（r=0.9999）,and 10.008 to 75.06 μg/ml for diazepam（r=0.9999）.The mean recovery of aminophylline,dexamethasone sodium phosphate and diazepam was 99.58%,99.97%,99.74%,respectively.Conclusion This method is quick and simple,which may be used for the simultaneous determination of the three constituents in Gaoyuankang capsules.