高效液相色谱法同时测定复方苯甲酸软膏中两组分含量

Simultaneous Determination of Benzoic Acid and Salicylic Acid in Compound Benzoic Acid Ointment by HPLC

目的 :建立以高效液相色谱法同时测定复方苯甲酸软膏中苯甲酸和水杨酸含量的方法。方法 :以HypersilODS为色谱柱 ,磷酸二氢钾溶液为流动相 -甲醇 (78∶22) ,检测波长为254nm。结果 :苯甲酸、水杨酸的线性范围分别为0 4～2 0mg/ml(r=0 9999)、0 2～1 0mg/ml(r=0 9999) ;回收率分别为98 74 % (RSD=0 55 % )、98 67 % (RSD=0 59 % ) ;日内相对标准差分别为0 56 %、0 73 % (n=5) ,日间相对标准差分别为0 75 %、0 82 % (n=5)。结论 :本法可用于复方苯甲酸软膏的含量测定和质量控制 ,且简便、快速、准确。

OBJECTIVE:To develop a RP-HPLC method for simultaneous determination of benzoic acid and salicylic acid in compound benzoic acid ointment.METHODS:Chromatographic condition included Hypersil ODS column and mobile phase of a mixture of potassium dihydrogen phosphate-methanol(78∶22),the detection wavelength was254nm.RESULTS:The linear ranges of benzoic acid and salicylic acid were0.4～2.0mg/ml(r=0.9999)and0.2～1.0mg/ml(r=0.9999);the average reˉcoveries were98.74%(RSD=0.55%)and98.67%(RSD=0.59%);the intra-day RSDs were0.56%and0.73%(n=5);the inter-day RSDs were0.75%and0.82%(n=5)respectively.CONCLUSION:This method is simple,accurate and quick,and can be used for the quality control of the preparation.