HPLC法测定复方酞丁安／达克罗宁搽剂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复方酞丁安／达克罗宁搽剂中酞丁安和达克罗宁及其有关物质含量的方法。方法：色谱柱为MACHEREY—NAGEL C18流动相为甲醇-乙腈-0．02mol·L-1磷酸二氢钾水溶液-三乙胺（25：25：50：0．3，磷酸调pH至4．0），流速为1．0mL·min-1，检测波长为295[IHI。结果：各杂质峰与主药峰之间达到基线分离，酞丁安和达克罗宁检测浓度的线性范围分别为20．63-72．21μg·mL-1（r=0．9999）、20．44～71．54μg·mL-1（r=0．9999）；平均回收率分别为98．7％、99．2％；日内RSD分别为0．97％、1．10％；日间RSD分别为1．52％、1．75％；最低检测限分别为0．4、0．2ng；3批样品中有关物质的含量分别为0．43％～0．68％。结论：本方法简便快速、专属性强、结果准确、重复性好，可用于该制剂的质量控制。

Determination of Principal Agents and the Related Substances of Compound Ftibamzone/ Dyclonine Liniment by HPLC

OBJECTIVE： To establish a HPLC method for determination of the principal components and the related substances in compound ftibamzone/ dyclonine liniment. METHODS： The determination was performed on MACHEREY- NAGEL C18 chromatographic column with the mobile phase consisted of methanol - acetonitrile 0.02 mol · L -1 potassium dihydrogen phosphate solution triethylamine （25 ： 25 ： 50 ： 0.3, pH value adjusted to 4.0 by the phosphoric acid） with a flow rate of 1.0 mL · min-1. The UV detection wavelength was set at 295 nm. RESULTS： A baseline separation was achieved between foreign materials＇ peaks and the principal agents＇ peaks. The calibration curve of ftibamzone and dyclonine were linear within the ranges of 20.63--72.21 μg·mL-1（r = 0.999 9） and 20.44--71.54 μg·mL-1（r = 0.999 9）, respectively; the average recovery rate was 98.7% vs. 99.2% ; the interday RSD was 0.97% vs. 1.10% ; the intra day RSD was 1.52% vs. 1.75% , and the lowest detective limit was 0.4 ng vs. 0.2 ng. The contents of the related substances were ranged from 0.43% to 0.68%. CONCLUSION： This method is simple, rapid, specific, accurate and reproducible, and it can be used for the quality control of the compound ftibamzone/dyclonine liniment.