目的:建立高效液相色谱法(high-performance liquid chromatography, HPLC)测定曲伏前列素滴眼液中曲伏前列素含量。方法:采用Dikma C18色谱柱(50 mm×4.6 mm, 3 μm);以磷酸溶液(取磷酸1.0 mL,用水稀释至1 000 mL,用1 mol/L氢氧化钠溶液调节pH至2.8)-乙腈(67:33)为流动相;流速为每分钟3.0 mL;柱温为25℃;检测波长为220 nm;进样体积30 μL。结果:曲伏前列素在20.28~70.98 μg /mL(r = 0.999 5)范围内线性关系良好,平均回收率为100.3%,相对标准偏差(relative standard deviatio, RSD)为2.0% (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48 h基本稳定。结论:该方法可用于曲伏前列素滴眼液中的曲伏前列素含量测定。
Objective: To establish a high-performance liquid chromatography (HPLC) method for the determination of content of Travoprost in Travoprost Eye Drops. Methods: The analytic column was Dikma C18 (50 mm×4.6 mm, 3 μm) . Using phosphoric acid solution (take 1.0 mL of phosphoric acid, dilute with water and make up to 1 000 mL, adjust the pH to 2.8 with 1 mol/L sodium hydroxide solution)-acetonitrile (67:33) as mobile phase. The flow rate is 3.0 mL/min. The column temperature is 25 ℃; The detection wavelength is 220 nm. The injection volume is 30 μL. Results: The linear range of travoprost showed were well shown within 20.28-70.98 μg/mL(r=0.998). The average recovery rate of travoprost was 100.3% with relative standard deviation (RSD) 2.0% (n=9). The method had high reproducibility. The reference solution and the test solution remain stable at room temperature for 48 hours. Conclusion: The method can be used for the determination of content of travoprost in Travoprost Eye Drops.