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反相HPLC法同时测定复方氧氟沙星滴眼液中氧氟沙星和地塞米松磷酸钠的含量及有关物质
引用本文:王国兰,寇晋萍,王俊秋,余立,周立春.反相HPLC法同时测定复方氧氟沙星滴眼液中氧氟沙星和地塞米松磷酸钠的含量及有关物质[J].中国药品标准,2010,11(3):195-198.
作者姓名:王国兰  寇晋萍  王俊秋  余立  周立春
作者单位:北京市药品检验所,北京,100035
摘    要:目的:建立反相高效液相色谱法测定复方氧氟沙星滴眼液中氧氟沙星和地塞米松磷酸钠的含量及有关物质。方法:反相高效液相色谱法,用资生堂SHISEIDOC18(UG120,4.6mm×250mm,5μm)色谱柱;以醋酸铵高氯酸钠溶液(取醋酸铵2.4g和高氯酸钠4.2g,用水900mL使溶解,用磷酸调pH值至2.5,再加水稀释至1000mL)+乙腈一甲醇(68:22:10)为流动相;检测波长有关物质为242μm和293nm,含量测定为254nm。结果:氧氟沙星和地塞米松磷酸钠的最低检测限分别为0.07ng和0.25ng;氧氟沙星在0.09~0.27g·L、地塞米松磷酸钠在0.03~0.09g·L。的范围内浓度与峰面积呈良好的线性关系,线性回归方程分别为C=3.5×10A-4.5×10。(r=1.000)和C=4.4×10-8-1.1×10-4(r=1.000);两组分的回收率分别为100.1%和100.6%,相对标准偏差(RSD)为0.89%和1.32%。结论:本方法灵敏、准确、专属性强可用于测定复方氧氟沙星滴眼液中两组分的含量和有关物质。

关 键 词:氧氟沙星  地塞米松磷酸钠  反相高效液相色谱法

Content Determination of Ofloxacin and Dexamethasone and Its Related Substance in Compound Ofloxacin Ophthalmic Solutions by RP-HPLC
Authors:Wang Guo-lan  Kou Jin-ping  Wang Jun-qiu  Yu Li and Zhou Li-chun
Affiliation:(Beijing Institute for Drug Control, Beifing 100035, China)
Abstract:Objective: To establish a RP-HPLC method for the content determination of Ofloxacin and Dexamethasone and its related substance in Compound Ofloxacin Ophthalmic Solutions. Methods:RP-HPLC method, the chromatographic column was SHISEIDO C18 (UG120,4. 6 mm × 250 mm ,5 μm) ; the mobile phase consisted of ammonium acetate and sodium perchlorate solution( dissolve 2.4 g ammonium acetate and 4. 2 g sodium perchlorate to 900 mL with water , adjusted pH to 2. 5 with phosphoric acid, dilute to 1 000 mL with water)- acetonitrile-methanol (68: 22: 10) ; detecting wavelength at 242 nm and 293nm for relative substance; 254 nm for content. Results : Lowest detectable limit were 0.07 ng and 0. 25 ng for Ofloxaein and Dexamethasone respectively, the linear ranges were 0. 09-0. 27 g . L-1 (r = 1. 000) and 0. 03-0. 09 g . L-1 (r = 1. 000) for Ofloxaein and Dexamethasone respectively, the recovery were 100. 1% and 100. 6% respectively, RSD were 0. 89% and 1.32% respectively. Conclusion: The method was sensitive,accurate and high specific for content determination of Ofloxacin and Dexamethasone in and its related substance Compound Ofloxacin Ophthalmic Solutions
Keywords:Ofloxacin  Dexamethasone  RP-HPLC
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