HPLC法测定水杨酸软膏中主药及有关物质的含量

目的:建立以高效液相色谱法测定水杨酸软膏中主药及有关物质含量的方法。方法:色谱柱为Kromasil C18,流动相为甲醇-水(冰醋酸调节pH至2.5)=50∶50,检测波长为270nm,流速为1.0mL·min-1,进样量为20μL。结果:主峰与有关物质可完全分离,水杨酸检测浓度的线性范围为10.014～100.14μg.mL-1(r=0.9999),平均回收率为99.35%,RSD=0.99%,最低检测限为5ng·mL-1,有关物质标示量均小于1.01%。结论:本方法操作简便、结果准确、专属性强,可用于该制剂的含量测定。

Determination of Salicylic Acid and the Related Substances in Salicylic Acid Ointment by HPLC

OBJECTIVE： To determine the contents of salicylic acid and the related substances in salicylic acid ointment by HPLC. METHODS： The determination was performed on Kromasil ODS - C18 chromatographic column with mobile phase consisted of methanol-water （adjust pH= 2.5 using acetic acid, 50 ： 50） at a flow rate of 1.0 mL·min^-1. The sample size was 20uL and the detection wavelength was set at 270 nm. RESULTS： The main peak and the related substances were well - separated. The linear range of salicylic acid was 10.014-100.14ug· mL^-1 （ r = 0.999 9） with an average recovery of 99.35% （RSD = 0.99% ） and a lowest detectable limit of 5 ng· mL^-1 the labeled amour of related substances all less than 1.01%. CONCLUSION： The method developed in our study is simple in operation, accurate in results, specific and suitable for the content determination of salicylic acid ointment.