高效液相色谱法测定双氯芬酸钠喷雾剂的含量

Determination of Diclofenac Sodium Content in Diclofenac Sodium Spray by HPLC

目的建立测定双氯芬酸钠喷雾剂中主药含量的高效液相色谱(HPLC)法。方法色谱柱为C18柱(250mm×4.6mm,5μm),流动相为甲醇-水-冰醋酸(80:20:0.8),流速为1.0mL/min,柱温为室温,检测波长为284nm。结果双氯芬酸钠质量浓度在20～70μg/mL范围内与峰面积线性关系良好,r=0.9999(n=6)。平均加样回收率为100.56%,RSD=0.86%(n=6)。结论 HPLC法简便、快速、准确、专属性强,可用于双氯芬酸钠喷雾剂的含量测定。

Objective To establish a HPLC method for the determination of diclofenac sodium in Diclofenac Sodium Spray.Methods The determination was performed on C18 column（250 mm × 4.6 mm,5 μm） with the mobile phase consisted of methanol-water-glacial acetic acid（80：20：0.8） and the column temperature was ambient temperature.The flow rate was 1.0 mL /min.The detection wavelength was set at 284 nm.Results The method showed a good linear relationship within the range of 20-70 μg /mL for diclofenac sodium,r = 0.999 9（n = 6）.The average recovery rate was 100.56% and RSD = 0.86%（n = 6）.Conclusion The determination method is simple,rapid,accurate and specific,which can be used for the content determination of diclofenac sodium in Diclofenac Sodium Spray.