HPLC法测定复方盐酸左氧氟沙星滴眼液中3组分的含量  

Simultaneous Determination of Three Components in Compound Levofloxacin Hydrochloride Eye Drops by HPLC

作　　者：刘世萍[1] 马妍妍[1] 郭美华[1] 白建海[2] 杨丽杰[1] 王琪[1] 

机构地区：[1]哈尔滨医科大学附属第一医院药学部,哈尔滨150001 [2]哈尔滨医科大学附属第一医院眼科

出　　处：《中国药师》2013年第11期1708-1710,共3页China Pharmacist

摘　　要：目的:建立高效液相色谱法测定盐酸左氧氟沙星滴眼液中盐酸左氧氟沙星、盐酸萘甲唑啉及地塞米松磷酸钠含量的方法。方法:色谱柱为Kromasil C_(18)柱(250 mm×4.6 mm,5μm),流动相为三乙胺溶液-甲醇-乙腈(50:45:5),流速1.0 ml·min^(-1),检测波长222 nm,柱温为25℃,进样量10μl。结果:盐酸左氧氟沙星、盐酸萘甲唑啉及地塞米松磷酸钠的线性范围分别为0.124 3~2.486 0μg(r=0.999 9),0.011 3~0.226.0μg(r=0.999 9),0.040 5~0.810 0μg(r=0.999 9),平均回收率分别为99.22%(RSD=0.72%,n=9),99.87%(RSD=0.86%,n=9),100.02%(RSD=0.91%,n=9)。结论:本方法简单、快速、准确,可用于该制剂的质量控制。Objective： To establish a method for the simultaneous determination of three components in compound levofloxacin hydrochloride eye drops by HPLC. Method： A Kromasil C18 column（250 mm x 4.6 mm,5 Ixm） was used with triethylamine solution- methanol-acetonitrile（50： 45：5 ） as the mobile phase at flow rate of 1.0 ml ~ min -J. The detection wavelength was 222 nm, the column temperature was kept at 25~C and the sample size was 10 p^l. Result： Linear regression equation of levofloxacin hydrochloride, naph- con hydrochloride and dexamethasone sodium phosphate was linear within the range of 0. 124 3-2. 486 /~g（ r = 0. 999 9）, 0.011 3 - 0. 226 0 g（ r = 0.999 9）and 0. 040 5-0.810 0 ~g （r = 0. 999 9 ）, respectively. The average recovery of the three components was 99.22% （ RSD = 0.72%, n = 9 ）, 99.87% （ RSD = 0.86%, n = 9 ） and 100.02% （ RSD = 0.91%, n = 9 ）, respectively. Conclusion ： The method is simple, rapid and accurate, and can be used in the quality control of the preparation.

关 键 词：高效液相色谱法 复方盐酸左氧氟沙星滴眼液 盐酸左氧氟沙星 盐酸萘甲唑啉 地塞米松磷酸钠 含量测定 

分 类 号：R927.2[医药卫生—药学]