高效液相色谱法测定复方地塞米松搽剂中盐酸达克罗宁的含量分析

Determination of Hydrochloride dyclonine in compound Dexamethasone liniment by HPLC

目的建立采用高效液相色谱法测定复方地塞米松搽剂中盐酸达克罗宁的含量的方法。方法采用Kromasil C18柱(4.6mm×250mm,5μm),HPLC反相法进行分离,紫外检测器检测,流动相为乙腈-水-冰醋酸-三乙胺(45∶55∶0.5∶0.5);流速:1.5mL·min-1;测定波长:279nm;柱温:40℃:进样:20μL。结果该方法没有受到处方中基质干扰。盐酸达克罗宁的线性范围为0.1003～0.7021μg(r=0.9998,n=6),平均回收率分别为98.8%,RSD为0.97%(n=9)。结论该方法操作简便、准确、快速、重现性好,可用于复方地塞米松搽剂中盐酸达克罗宁的含量测定。

OBJECTIVE To establish the method to determine the content of hydrochloride Dyclonine in compound dexamethasone liniment by High Performance Liquid Chromatography. METHODS Kromasil C18 column （4.6mm×250mm,5μm） and RP HPLC was used for separation. UV detector was used for detection mobile phase of acetonitrile-water-acetic acid-triethylamine （45 ： 55：0. 5：0. 5 ） ; flow rate was 1.55mL·min^-1; measurement wavelength was 279nm;column temperature was 40℃;injection was 20μL. RESULTS The result of this method is not subject to the prescription of matrix interference. The hydrochloric Dyclonine linear range of 0. 100 ～ 0. 7021μg（ r = O. 9998,n =6） ,the average recoveries were 98.8% ,and RSD of 0. 97% （n =9）. CONCLUSION The method is simple, accurate, fast, good reproducibility and can be used for content determination of hydrochloride Dyclonine in compound dexamethasone liniment.