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引用本文:张福成,安静,卢彦芳,孙婷,蒋晔.葡聚糖凝胶色谱法分析注射用阿洛西林钠中的高聚物[J].中国现代应用药学,2011,28(3):257-260.
ZHANG Fucheng,AN Jing,LU Yanfang,SUN Ting,JIANG Ye.Determination of High Polymers in Azlocillin Sodium for Injection by Sephadex G-10 Gel Chromatography[J].Chin J Mod Appl Pharm(中国现代应用药学),2011,28(3):257-260.
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葡聚糖凝胶色谱法分析注射用阿洛西林钠中的高聚物
张福成1, 安静2, 卢彦芳2, 孙婷2, 蒋晔2
1.空军总医院药学部,北京 100036;2.河北医科大学药学院,石家庄 050017
摘要:
目的 建立一个简单分析阿洛西林钠中高聚物的方法。方法 采用SephadexTM G-10色谱柱,以0.1 mol·L-1磷酸盐缓冲液(氢氧化钠调pH 6.8)为流动相A,水为流动相B,流速1.5 mL·min-1,检测波长为254 nm。结果 阿洛西林钠中高聚物在0.001~4.08 mg·mL-1内线性关系良好,检测限为0.5 μg·mL-1。当供试品溶解量为200 mg·mL-1时,本法的高聚物检出能力达到百万分之三。结论 所用方法简便,结果可靠,可用于阿洛西林钠中高聚物的检测。
关键词:  阿洛西林钠  高聚物  葡聚糖凝胶色谱
DOI:
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Determination of High Polymers in Azlocillin Sodium for Injection by Sephadex G-10 Gel Chromatography
ZHANG Fucheng1, AN Jing2, LU Yanfang2, SUN Ting2, JIANG Ye2
1.Department of Pharmacy, General Hospital of Air Force, Beijing 100036, China;2.School of Pharmacy, Hebei Medical University, Shijiazhuang 050017, China
Abstract:
OBJECTIVE To develop a simple method for the determination of high polymers in azlocillin sodium for injection. METHODS A SephadexTM G-10 column was used with the mobile phase A of 0.10 mol·L-1 phosphate buffer (adjust to pH 6.8 with NaOH) at a flow rate of 1.5 mL·min-1. And the mobile phase B was pure water, the detection wavelength was 254 nm. RESULTS The calibration curve was linear in the range of 0.001-4.08 mg·mL-1 and the detection limit of high polymers was 0.5 μg·mL-1. The detection potential of high polymers achieved 3 ppm by the method when the dissolved load of azlocillin sodium was 200 mg·mL-1. CONCLUSION The proposed method is simple and reliable. It is applicable for the quality control of azlocillin sodium.
Key words:  azlocillin sodium  high polymers  Sephadex G-10 gel chromatograph
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