Determination of Salicylic Acid and the Related Substances in Salicylic Acid Ointment by HPLC / 中国药房

ABSTRACT

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 20 ?L 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 10.014～100.14 ?g?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 amout 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.