中国临床药学杂志

目的建立同时测定新型浓苯甲酸水杨酸软膏中苯甲酸和水杨酸浓度的RP-HPLC法。方法采用Kromasil-C₁₈(150 mm×4.6 mm,5μm)色谱柱;流动相为V(甲醇):V(0.02 mol·L^-1,KH_2PO₄溶液,磷酸调pH=3.1)=50:50;检测波长280nm;流速1.0 mL·min^-1;柱温20℃。结果苯甲酸、水杨酸进样质量浓度分别为96～144 mg·L^-1(r=0.999 5)、48～72 mg·L^-1(r=0.999 7)时具良好线性关系,加样回收率分别为99.6%～100.6%、99.4%～100.2%,批间、批内RSD为0.3%～0.7%。结论本方法简便、精确、重现性好,适用于测定新型浓苯甲酸水杨酸软膏中苯甲酸和水杨酸浓度。

AIM To establish a method for the simultaneous content determination of benzoic acid and salicylic acid in a new concentrated benzoic acid and salicylic acid ointment by RP-HPLC.METHODS A Kromasil-C₁₈chromatographic column(150 mm×4.6 mm,5μm)was used;the mobile phase was V(methanol):V(0.02 mol·L^-1 KH_2PO₄,the pH value was adjusted to 3.1 with H_3PO₄ solution)=50:50;the determination wave length was 280 nm;the flow rate was 1.0 mL'min"1 and the column temperature was 20℃.RESULTS The linear ranges of benzoic acid and salicylic acid were 96-144 mg·L^₁(r=0.9995)and 48-72 mg·L^-1(r=0.999 7),respectively.Their average recoveries were within 99.6%-100.6%and 99.4%-100.2%.respectively.CONCLUSION The method is simple, accurate,reproducible and suitable for the determination of benzoic acid and salicylic acid levels in a new concentrated benzoic acid and salicylic acid ointment.