高效液相色谱法测定复方苯甲酸乳膏中苯甲酸和水杨酸的含量

目的:建立高效液相色谱法(HPLC)测定复方苯甲酸乳膏中苯甲酸和水杨酸的含量。方法:色谱柱为Hypersil C_(18)柱(4.6nm×250mm,5μm),流动相为甲醇-水(44:56),流速0.8mL·min~(-1),检测波长为226nm。结果:苯甲酸和水杨酸分别在15.20～76.00mg·L~(-1)和7.64～38.20mg·L~(-1)范围内线性良好(r=0.9999);日内、日间RSD在0.030～4.79％,高、中、低浓度回收率在98.54％～101.20％。分析了3批样品,结果满意。结论:本方法简便,快速,准确,可作为复方苯甲酸乳膏的质量控制方法。

HPLC determination of benzoic acid and salicylic acid in compound benzoic acid cream

OBJECTIVE To determine benzoic acid and salicylic acid in compound benzoic acid cream by RP-HPLC. METHODS The chromatographic conditions were as follows:Hypersil C18 column(4.6 mmx 250 mm,5 um) ,methanol and water(44:56)as mobile phase, at a flow rate of 0.8 mL.min-1 ,detection wavelength 226 ran. RESULTS The linear range of calibration curve of benzoic acid and salicylic acid was 15.20 -76.00 mg.L-1 ,7.64~38.20 mg.L-1(r = 0.9999), respectively. The RSD of intra-day and in-tcr-day assay was within 0.03% ~ 4.79% . The recovery of high, medium and low concentration was within 98.54%-101.20% . CONCLUSIONS The method was simple, rapid and accurate. It can be used for the quality control of compound benzoic acid cream.