高效液相色谱法测定曲伏前列素滴眼液中曲伏前列素含量  

Determination of content of travoprost in travoprost eye drops by HPLC

作　　者：陈婕婷 李裕军 翁少敏 CHEN Jieting;LI Yujun;WENG Shaomin(State Key Laboratory of Ophthalmology,Zhongshan Ophthalmic Center,Sun Yat-sen University,Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science,Guangzhou 510060,China)

机构地区：[1]中山大学中山眼科中心,眼病防治全国重点实验室,广东省眼科视觉科学重点实验室,广州510060

出　　处：《眼科学报》2024年第12期600-607,共8页Eye Science

摘　　要：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,3μm);以磷酸溶液(取磷酸1.0 mL,用水稀释至1000 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30μL。结果:曲伏前列素在20.28~70.98μg/mL(r=0.9995)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,3μm).Using phosphoric acid solution(take 1.0 mL of phosphoric acid,dilute with water and make up to 1000 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 30μL.Results:The linear range of travoprost showed were well shown within 20.28-70.98μg/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.

关 键 词：高效液相色谱法 滴眼液 曲伏前列素 含量 分析方法 

分 类 号：R774.1[医药卫生—眼科] R778.11[医药卫生—临床医学]