HPLC法同时测定双氯达克乳膏中2种主药及防腐剂的含量

Simultaneous Determination of 2 Kinds of Main Components and Preservative in Shuanglv Dake Cream by HPLC

目的:建立同时测定双氯达克乳膏中氯霉素、丙酸氯倍他索和防腐剂羟苯乙酯含量的方法。方法:采用高效液相色谱法,以醋酸氟轻松为丙酸氯倍他索的内标。色谱柱为XBridgeTMC18,流动相为0.02mol/L磷酸二氢钾-甲醇(35:65),流速为1.0ml/min,紫外检测波长为240nm,柱温为40℃。结果:氯霉素、丙酸氯倍他索和羟苯乙酯检测质量浓度线性范围分别为0.11～2.22、0.005～0.11、0.01～0.22mg/m(lr均≥0.9999,n=5),平均回收率分别为101.40%、98.31%、100.19%,RSD分别为0.70%、0.63%、0.75%(n=9)。结论:该方法准确度和回收率均符合要求,可用于控制双氯达克乳膏的质量。

OBJECTIVE：To establish a method for simultaneous determination of chloramphenicol,clobetasol propionate and ethylparaben in Shuanglv dake cream.METHODS：HPLC method was adopted using fluocinonide as internal standard for clobetasol propionate.The determination was carried out on XBridge TM C 18 column with 0.02 mol/L potassium dihydrogen phosphate-methanol（35：65）as mobile phase at flow rate of 1.0 ml/min.The UV detection wavelength was 240 nm,and the column temperature was 40 ℃.RESULTS：The linear ranges of chloramphenicol,clobetasol propionate and ethylparaben were 0.11-2.22 mg/ml,0.005-0.11 mg/ml and 0.01-0.22 mg/ml（r≥0.999 9,n=5）,respectively.The average recoveries were 101.40% for chloramphenicol（RSD=0.70%）,98.31% for clobetasol propionate（RSD=0.63%）and 100.19% for ethylparaben（RSD=0.75%）,respectively（n=9）.CONCLUSIONS：The accuracy and recovery of the method are in line with the standard.It can be applied for the quality control of Shuanglv dake cream.