HPLC法同时测定口腔溃疡糊剂中盐酸丁卡因和乳酸依沙吖啶的含量

Simultaneous Determination of Tetracaine Hydrochloride and Ethacridine Lactate in Stomatic Ulcer Paste by HPLC

目的建立口腔溃疡糊剂中盐酸丁卡因和乳酸依沙吖啶的含量测定方法。方法采用高效液相色谱(HPLC)法,色谱柱为Thermo Hypersil GOLD C 18(250mm×4.6mm,5μm),流动相为乙腈-50mmol·L^-1磷酸二氢钾(0.5%三乙胺,磷酸调节pH 3.0),流速为1.0mL·min^-1,检测波长270nm。结果盐酸丁卡因和乳酸依沙吖啶分别在4.02~20.08μg·mL^-1和2.00~10.00μg·mL^-1范围内线性关系良好(r>0.9999),平均加样回收率分别为99.65%、100.32%,相对标准偏差(RSD)分别为0.57%、0.73%。结论该方法操作简便、结果准确、重现性好,可作为控制口腔溃疡糊剂质量的方法。

OBJECTIVE To develop a method for the simultaneous determination of tetracaine hydrochloride and ethacridine lactate in stomatic ulcer paste.METHODS A high performance liquid chromatography method(HPLC)was employed.Chromatographic separation was performed on a Thermo Hypersil GOLD C 18(250mm×4.6mm,5μm)column with isocratic elution of acetonitrile-50mmol·L^-1 potassium dihydrogen phosphate buffer solution(0.5%triethylamine,pH 3.0)at a flow rate of 1.0mL·min^-1.The detection wavelength was 270nm.RESULTS The calibration curves were linear within the range of 4.02-20.08μg·mL^-1 for tetracaine hydrochloride and 2.00-10.00μg·mL^-1 for ethacridine lactate,respectively.The average recoveries of the two compounds were 99.65%and 100.32%with relative standard deviations of 0.57%and 0.73%for tetracaine hydrochloride and ethacridine lactate,respectively.CONCLUSION The method is easy to operate with accurate results and good reproducibility.It can be used effectively for the quality control of stomatic ulcer paste.