HPLC法同时测定盐酸去氧肾上腺素、托吡卡胺的含量  

HPLC simultaneous determination of phenylephrine hydrochloride and tropicamide in drop eye liquid

作　　者：孙玉静[1] 周丽[1] 王婷婷[1] 闫晓娜[1] 刘霞[1] 

机构地区：[1]沈阳华泰药物研究有限公司,沈阳110015

出　　处：《药物分析杂志》2009年第11期1944-1946,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC法同时测定复方托吡卡胺滴眼液中盐酸去氧肾上腺素、托吡卡胺的含量。方法:采用HypersilODS2 C18(250 mm×4.6 mm,5μm)为色谱柱,以甲醇∶水(0.2%辛烷磺酸钠及0.2%三乙胺水溶液,用磷酸调节pH至3.5)(45∶55)为流动相,流速1.0 mL.min-1,外标法测定,检测波长为220 nm。结果:两种成分分离良好,盐酸去氧肾上腺素浓度在10.0～100.0μg.mL-1范围内有良好的线性关系,r=0.9999;平均回收率为99.8%(n=9);最低检出限为0.0784μg.mL-1;最低定量限为0.2μg.mL-1。托吡卡胺浓度在9.84～98.4μg.mL-1范围内有良好的线性关系,r=0.9992;平均回收率为99.4%(n=9);最低检出限为0.2μg.mL-1;最低定量限为0.492μg.mL-1。结论:该方法准确、简便、快速,可用于同时测定滴眼剂中盐酸去氧肾上腺素、托吡卡胺的含量。Objective： To establish a HPLC method for the simultaneous determination of phenylephrine hydrochloride and tropicamide in eye drops. Method： The HPLC system consisted of Hyperdil ODS2 C18 column （250 mm×4.6 mm, 5 μm） , methand： water （0.2% sodium octanesulphonate and 0.2% triethylamine solution, adjust to pH 3.5 with phosphoric acid） （45﹕55） as mobile phase at the flow rate of 1.0 mL·min^-1, the detection wavelength was 220 nm. Results： Both constituents were separated effectively. There was good linear relationship with the concentration range of phenylephrine hydrochloride of 10.0-100.0mg·mL^-1 （r=0.9999） , the average recovery was 99.8% （n=9）; The limit of detection was 0.0784 mg·mL^-1 and the limit of quantification was 0.2 mg·mL^-1 . There was good linear relationship with the concentration range of tropicamide of 9.84-98.4 mg·mL^-1 （r=0.9992） , the average recovery was 99.4% （n=9）; The limit of detection was 0.2 mg·mL^-1 and the limit of quantification was 0.492 mg·mL^-1 . Conclusion： The method is rapid, simple, accurate for the simultaneous determination of both constituents in the eye drops.

关 键 词：高效液相色谱法 盐酸去氧肾上腺素 托吡卡胺 含量测定 

分 类 号：R917[医药卫生—药物分析学]