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医学免费论文:RP-HPLC法同时测定复方环昔滴眼液中两组分的含量
【摘要】 目的：建立同时测定复方环昔滴眼液中盐酸环丙沙星和阿昔洛韦的含量的RP-HPLC法。方法：采用Kromasil C18柱(4.6 mm×250 mm,5 μm)，以15∶15∶70比例的甲醇-乙腈-0.05 mol·L-1枸橼酸溶液(三乙胺调pH至3.5)为流动相，流速为0.8 mL·min-1;检测波长为253 nm。结果：盐酸环丙沙星和阿昔洛韦的线性范围分别为15.1～241.6 μg·mL-1(r=0.9993)和5.1～81.6 μg·mL-1(r=0.9998)，平均回收率分别为99.7%和99.8%，RSD分别为0.92%和0.65%。结论：本法快速准确，重现性好，适用于复方环昔滴眼液的质量控制。
【关键词】 反相高效液相色谱法;复方环昔滴眼液;盐酸环丙沙星;阿昔洛韦
Simultaneous Content Determination of Two Constituents in Compound Huanxi Eye-Drops by RP-HPLCZHU Xue-song，ZHU Yu， LI Chun-lei，ZHENG Fang Department of Pharmacy, Dongfeng Hospital,Yunyang Medical College,Shiyan,Hubei 442008,China)Abstract:Objective To establish a RP-HPLC method that can simultaneously determine the contents of ciprofloxacin hydrochloride and aciclovir in compound huanxi eye-drops.Methods The RP-HPLC was performed on a Kromasil C18 column (4.6 mm×250 mm,5 μm) , the mobile phase was composed of methanol-acetonitrile-0.05 mol·L-1 citric acid solution(adjusted to pH3.0 with triethylamine)with a ratio of 15∶15∶70, the flow rate was 0.8 mL·min-1, the detection wavelength was 253 nm.Results The linear ranges of ciprofloxacin hydrochloride and aciclovir were 15.1～241.6 μg·mL-1(r=0.9993)and 5.1～81.6 μg·mL-1( r=0.9998 ),respectively.The average recovery rates were 99.7% and 99.8% with RSD 0.92% and 0.65%，respectively.Conclusion The method is accurate and reliable for the quality control of compound huanxi eye-drops.
Key words:RP-HPLC;Compound huanxi eye-drops;Ciprofloxacin hydrochloride;Aciclovir医.学全.在.线网站www.lindalemus.com
复方环昔滴眼液是郧阳医学院附属东风总医院开发的自制制剂，主要有效成分为盐酸环丙沙星(以环丙沙星计3 mg·mL-1)和阿昔洛韦(1 mg·mL-1)，主要辅料为透明质酸钠(2 mg·mL-1)。其中盐酸环丙沙星是第三代喹诺酮类广谱抗菌药物，阿昔洛韦为高效抗病毒药;透明质酸钠作为主要的辅料，与眼球表面黏蛋白具有一种特殊的亲和力，故具有缓释、物理增黏和铺展润湿能力[1]。目前国内已有用高效液相色谱法测定其他制剂中盐酸环丙沙星和阿昔洛韦各自含量的报道[2-4]，但该制剂目前尚未见同时测定二者含量的方法报道，为更好地控制该产品的质量，本研究中建立了同时测定复方环昔滴眼液中盐酸环丙沙星和阿昔洛韦的含量的反相高效液相色谱法，该法简便、快速、准确，可作为复方环昔滴眼液的质量控制方法。
1 仪器与试药
1.1 仪器Ultimate 3000高效液相色谱仪(Ultimate 3000泵,Ultimate 3000二极管阵列检测器，四元低压混合系统，chromeleon工作站)，HS-2060超声仪,岛津AEU-210电子天平。
