目的：建立高效液相色谱法(high-performance liquid chromatography，HPLC)测定盐酸丁卡因滴眼液中盐酸丁卡因和羟苯乙酯的含量。方法：采用Agilent Eclipse PLUS C18色谱柱(250 mm ×4.6 mm，5 μm)；以1%三乙胺溶液(三乙胺10 mL，加水990 mL，用冰醋酸调节pH值至5.0±0.5)-乙腈(65 : 35)为流动相，流速为1.0 mL/min；柱温为30 ℃；检测波长为256 nm；进样体积20 μL。结果：盐酸丁卡因在0.05~0.36 mg/mL范围内线性关系良好( r =1.000)，平均回收率为99.2%，相对标准偏差(relative standard deviation，RSD)为0.3%(n=9)，羟苯乙酯在3.02~24.14 μg/mL范围内线性关系良好(r=1.000)，平均回收率为98.2%，RSD为0.4%(n=9)，该方法重现性好。对照品溶液和供试品溶液在室温放置24 h基本稳定；结论：本方法简便、快速、准确。适用于检测盐酸丁卡因滴眼液中盐酸丁卡因和羟苯乙酯的含量。

Objective: To establish a high-performance liquid chromatography (HPLC) method for the determination of tetracaine hydrochloride and ethyl hydrobenzoate in tetracaine hydrochloride eye drops. Methods: The analytic column was Agilent Eclipse Plus C18 (4.6 mm ×250 mm, 5 μm) and the mobile phase was 1% triethylamine solution (10 mL triethylamine and 990 mL water, pH adjusted to 5.0±0.5 with glacial acetic acid) - acetonitrile (65:35) at a flow rate of 1.0 mL/min. The detection wavelength was 256 nm and the column temperature was 30 ℃. The injection volume was 20 μL. Results: The linear range of tetracaine hydrochloride was well shown within 0.05–0.36 mg/mL (r=1.000). The average recovery rate of tetracaine hydrochloride was 99.2% with relative standard deviation (RSD) 0.3% (n=9). The linear range of ethyl hydrobenzoate was well shown within 3.02–24.14 μg/mL (r=1.000). The average recovery rate of tetracaine hydrochloride was 98.2% with RSD 0.4%(n=9). The method had high reproducibility. The reference solution and testing solution were stable for 24 h in room. Conclusion: The method is simple, quick and accurate, which is suitable for the determination of tetracaine hydrochloride and ethyl hydrobenzoate in tetracaine hydrochloride eye drops.