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本文建立了用 HPLC 法测定原料药和制剂中三种氟喹诺酮类合成广谱抗生素——替马氟沙星(temafloxacin)、沙拉氟沙星(sarafloxacin)和双氟沙星(difloxacin)含量的方法。色谱条件 Nucleosil C_(18)柱(5μm,4.6mm×15cm),流动相为缓冲溶液,(0.02mol/L 柠檬酸-0.02mol/L 柠檬酸钠,高氯酸调 pH 至2.4):乙腈(65:35,v/v),流速1.0ml/min,检测波长280nm,进样量50μl。以对-硝基苯乙酮为内标,一点校正法定量。、样品溶液的制备原料药:将三种药分别溶于乙腈/水(1:1),制成1.2 mg/ml(游离碱浓度)的储备液,再用乙腈/水(1:1)怖释至约12弘g/ml,并加入内标使其浓度约为14腭/ml。同法制备参比标准溶液。片剂及胶囊:取片剂20片研磨或胶囊20粒的内容物混合,取样(相当于100 mg药物)用乙腈/水(1:’1)提取并稀释至100 ml,待赋形剂沉降后,按原料药项下稀释制备。羟丙基甲基纤维
In this paper, a method for the determination of three broad-spectrum antibiotics, temafloxacin, sarafloxacin and difloxacin, of three fluoroquinolones in pharmaceutical raw materials and preparations by HPLC was established. . The chromatographic conditions Nucleosil C_ (18) column (5μm, 4.6mm × 15cm), the mobile phase buffer solution (0.02mol / L citric acid - 0.02mol / L sodium citrate, 65:35, v / v), flow rate 1.0ml / min, detection wavelength 280nm, injection volume 50μl. With p-nitroacetophenone as an internal standard, a little calibration method. Preparation of sample solution Raw material drug: Dissolve the three drugs in acetonitrile / water (1: 1) respectively to prepare a stock solution of 1.2 mg / ml (free base concentration), then neutralize with acetonitrile / water Release to about 12 g / ml, and add the internal standard to a concentration of about 14 palate / ml. The same method of preparing reference standard solution. Tablets and Capsules: Twenty tablets of ground tablets or 20 capsules of capsules are mixed and sampled (equivalent to 100 mg of drug) extracted and diluted to 100 ml with acetonitrile / water (1: 1) until the excipients settle After preparation, according to the raw materials diluted. Hydroxypropyl methylcellulose