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醫(yī)學(xué)免費論文:RP-HPLC法同時測定復(fù)方環(huán)昔滴眼液中兩組分的含量
【摘要】 目的：建立同時測定復(fù)方環(huán)昔滴眼液中鹽酸環(huán)丙沙星和阿昔洛韋的含量的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枸櫞酸溶液(三乙胺調(diào)pH至3.5)為流動相，流速為0.8 mL·min-1;檢測波長為253 nm。結(jié)果：鹽酸環(huán)丙沙星和阿昔洛韋的線性范圍分別為15.1～241.6 μg·mL-1(r=0.9993)和5.1～81.6 μg·mL-1(r=0.9998)，平均回收率分別為99.7%和99.8%，RSD分別為0.92%和0.65%。結(jié)論：本法快速準確，重現(xiàn)性好，適用于復(fù)方環(huán)昔滴眼液的質(zhì)量控制。
【關(guān)鍵詞】 反相高效液相色譜法;復(fù)方環(huán)昔滴眼液;鹽酸環(huán)丙沙星;阿昔洛韋
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醫(yī).學(xué)全.在.線網(wǎng)站gydjdsj.org.cn
復(fù)方環(huán)昔滴眼液是鄖陽醫(yī)學(xué)院附屬東風(fēng)總醫(yī)院開發(fā)的自制制劑，主要有效成分為鹽酸環(huán)丙沙星(以環(huán)丙沙星計3 mg·mL-1)和阿昔洛韋(1 mg·mL-1)，主要輔料為透明質(zhì)酸鈉(2 mg·mL-1)。其中鹽酸環(huán)丙沙星是第三代喹諾酮類廣譜抗菌藥物，阿昔洛韋為高效抗病毒藥;透明質(zhì)酸鈉作為主要的輔料，與眼球表面黏蛋白具有一種特殊的親和力，故具有緩釋、物理增黏和鋪展?jié)櫇衲芰1]。目前國內(nèi)已有用高效液相色譜法測定其他制劑中鹽酸環(huán)丙沙星和阿昔洛韋各自含量的報道[2-4]，但該制劑目前尚未見同時測定二者含量的方法報道，為更好地控制該產(chǎn)品的質(zhì)量，本研究中建立了同時測定復(fù)方環(huán)昔滴眼液中鹽酸環(huán)丙沙星和阿昔洛韋的含量的反相高效液相色譜法，該法簡便、快速、準確，可作為復(fù)方環(huán)昔滴眼液的質(zhì)量控制方法。
1 儀器與試藥
1.1 儀器Ultimate 3000高效液相色譜儀(Ultimate 3000泵,Ultimate 3000二極管陣列檢測器，四元低壓混合系統(tǒng)，chromeleon工作站)，HS-2060超聲儀,島津AEU-210電子天平。
