医院制剂苯甲酸水杨酸软膏中主药含量检测方法改进

Improvement of Determination Methods for Main Ingredients in Hospital Preparation of Benzoic Acid and Salicylic Acid Ointment

目的采用RP-HPLC法同时测定苯甲酸水杨酸软膏中苯甲酸和水杨酸的含量。方法采用Kromasil C18色谱柱,以甲醇-水-冰醋酸（50∶50∶1）为流动相,检测波长：270nm,流速：1.0mL·min^-1,柱温：30℃。结果苯甲酸、水杨酸分别在122.2～1221.6μg·mL^-1、59.8～598.0μg·mL^-1范围内具有良好的线性关系（r=0.9998）;回收率分别为99.2%、99.6%,RSD分别为0.6%、0.4%。结论本法经方法学验证可用于苯甲酸水杨酸软膏中主要成分的含量测定,可作为该医院制剂质量标准修订的依据。

Objective To establish a method for content determination of benzoic acid and salicylic acid in benzoic acid and salicylic acid ointment by RP-HPLC.Methods The Kromasil C18 column was adopted.The mobile phase consisted of methanol-water-acetic acid（50∶50∶1）.The detection wavelength was set at 270 nm.The flow rate was 1.0mL·min^-1.The column temperature was 30℃.Results The linear ranges of benzoic acid and salicylic acid were 122.2-1221.6μg·mL^-1 and 59.8-598.0μg·mL^-1（r=0.9998）.The average recoveries were 99.2%（RSD=0.6%）and 99.6%（RSD=0.4%）.Conclusion The method can be used for content determination of the main ingredients in benzoic acid and salicylic acid ointment,and can be used as the basis of quality standard revision for the hospital preparation.