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目的建立高效液相色谱法同时测定复方盐酸丁卡因凝胶中有效成分盐酸丁卡因、乳酸依沙吖啶含量的方法。方法采用Thermo Hypersil BDS C18色谱柱(4.6 mm×150 mm,5μm),以乙腈-水-三乙胺(30∶70∶0.5)为流动相,双通道检测波长为270 nm和310 nm,流速为1 m L·min?1,进样量为10μL。结果盐酸丁卡因在40.0~160.0 mg·L?1内峰面积与浓度呈良好的线性关系(r=0.999 9),平均回收率为100.2%,RSD为2.08%;乳酸依沙吖啶在38.1~152.4 mg·L?1内峰面积与浓度呈良好的线性关系(r=0.999 8),平均回收率为99.7%,RSD为1.71%。结论本法简便、准确、重复性好,可用于复方盐酸丁卡因凝胶中盐酸丁卡因和乳酸依沙吖啶的含量测定。
Objective To establish a method for simultaneous determination of tetracaine hydrochloride and tetracaine hydrochloride in compound tetracaine hydrochloride gel by high performance liquid chromatography. Methods The mobile phase was acetonitrile-water-triethylamine (30:70:0.5) with a mobile phase of Thermo Hypersil BDS C18 (4.6 mm × 150 mm, 5 μm). The detection wavelength was 270 nm and 310 nm. The flow rate was 1 m L · min -1, the injection volume of 10μL. Results The peak area of tetracaine hydrochloride in the range of 40.0-160.0 mg · L -1 was linear with the concentration (r = 0.999 9), with an average recovery of 100.2% and a RSD of 2.08%. In the 38.1 ~ 152.4 mg · L -1 showed a good linear relationship with the concentration (r = 0.999 8). The average recovery was 99.7% and the RSD was 1.71%. Conclusion This method is simple, accurate and reproducible. It can be used for the determination of tetracaine hydrochloride and ethacridine lactate in compound tetracaine hydrochloride gel.