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目的:建立用Sephadex G-10凝胶色谱法分析头孢克洛胶囊中高分子聚合物的方法。方法:色谱柱:Sephadex G-10柱(300 mm×15.0 mm,40～120μm);流动相A:pH 7.0的0.05 mol·L~(-1)磷酸盐缓冲液[0.05 mol·L~(-1)磷酸氢二钠溶液-0.05mol·L~(-1)磷酸二氢钠溶液(95:5)];流动相B:超纯水;检测波长:254 nm;流速:1.5 ml·min~(-1)。以头孢拉定作对照加校正因子外标法定量(头孢克洛:头孢拉定=1:1)。结果:头孢克洛聚合物在1～20μg·ml~(-1)范围内呈良好的线形关系(r=0.9992)。结论:方法简便易行,能较好分离头孢克洛与其聚合物,且精密度、准确度均能满足质量控制的要求。
OBJECTIVE: To establish a method for the determination of high molecular weight polymers in cefaclor capsules by Sephadex G-10 gel chromatography. METHODS: Sephadex G-10 column (300 mm × 15.0 mm, 40-120 μm) was used as the mobile phase. The mobile phase A was 0.05 mol·L -1 phosphate buffer solution (pH 7.0) 1) Disodium hydrogen phosphate solution - 0.05 mol·L -1 sodium dihydrogen phosphate solution (95: 5)]; mobile phase B: ultrapure water; detection wavelength: 254 nm; flow rate: 1.5 ml · min ~ (-1). Cefradizime as a control plus calibration factor external standard (cefaclor: cephradine = 1: 1). Results: Cefaclor polymer showed good linearity in the range of 1 ~ 20μg · ml ~ (-1) (r = 0.9992). Conclusion: The method is simple and easy, and can separate cefaclor and its polymer well. The precision and accuracy can meet the requirements of quality control.