复方氯己定达克罗宁乳膏含量测定方法研究

Study on content determination method in Compound Chlorhexidine Dihydrochloride and Dyclonine Hydrochloride Cream

目的建立反相高效液相层析(RP-HPLC)法同时测定复方氯己定达克罗宁乳膏中两种成分含量的方法,用于制定复方氯己定达克罗宁乳膏的质量标准。方法采用C18(250 mm×4.6 mm,5μm)色谱柱,流动相,乙腈∶0.05moL/L磷酸二氢钾溶液(含0.07%庚烷磺酸钠,0.4%三乙胺,用磷酸调pH至3.0),流速1.0 mL/min,检测波长284 nm,柱温25℃。结果盐酸氯己定、盐酸达克罗宁的线性范围分别为0.100 03～2.000 60μg和0.015 18～0.303 60μg,相关系数均为0.999 99,回收率(n=9)分别为99.83%和99.89%,相对标准偏差(RSD)分别为0.41%和0.14%。结论该方法简便、准确,可作为控制复方氯己定达克罗宁乳膏中盐酸达克罗宁、盐酸氯己定含量的质量标准。

Objective To establish a RP-HPLC method to simultaneously determine the contents of two components in Compound Chlorhexidine Dihydrochloride and Dyclonine Hydrochloride Cream for establishing the quality standards of this preparation.Methods The chromatographic analysis was performed on the C18 column（250 mm×4.6 mm,5 μm） with acetonitrile-0.05mol/L KH2PO4 solution（containing 0.07% sodium heptane-1-sulphonate and 0.4%triethylamine,adjusting to pH 3.0 with orthophosphoric acid）.The flow rate was 1.0 mL/min with the detection wavelength at 284 nm and the colum temperature at 25 ℃.Results The calibration curves showed the good linearity in the range of 0.100 03-2.000 60 μg for chlorhexidine dihydrochloride and 0.015 18-0.303 60 μg for dyclonine hydrochloride,the correlation coefficients 0.999 99 and 0.999 99 respectively.The average recoveries（n=9）were 99.83% and 99.89%,RSD 0.41% and 0.14%,respectively.Conclusion The method is simple,accurate and can be used for the quality control of chlorhexidine dihydrochloride and dyclonine hydrochloride in Compound Chlorhexidine Dihydrochloride and Dyclonine Hydrochloride Cream