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目的建立氟氯西林钠胶囊、注射用氟氯西林钠的高分子聚合物检查方法。方法采用凝胶色谱法,色谱柱为Sephadex G10,流动相A为0.1mol/L磷酸盐缓冲液(pH7.0),流动相B为水;流速为1.2m L/min;检测波长为254nm,进样量为100μL,自身对照外标法定量。结果建立了氟氯西林钠中高分子聚合物检测方法;本方法线性范围为10～245μg/m L(0.9995);检出限与最低定量限分别为5.8μg/m L,9.8μg/m L;精密度和重复性均符合色谱要求(RSD=0.26%,3.5%)。采用该方法对9批注射用氟氯西林钠、7批氟氯西林钠胶囊中高分子聚合物含量的进行检测,结果均<0.2%。结论该方法能够较好的分离氟氯西林钠主成分及高分子聚合物、低聚体杂质,可用于氟氯西林钠胶囊、注射用氟氯西林钠中高分子聚合物的检验。
Objective To establish a method for the examination of high molecular weight polymers of flucloxacillin sodium capsules and flucloxacillin sodium for injection. Methods The column was Sephadex G10, the mobile phase A was 0.1 mol / L phosphate buffer (pH 7.0), the mobile phase B was water, the flow rate was 1.2 m L / min, the detection wavelength was 254 nm, Injection volume of 100μL, its own control of external standard quantitative. Results The method for the determination of mid and high molecular weight flucloxacillin sodium was established. The linear range of this method was 10-245μg / m L (0.9995). The limits of detection were 5.8μg / m L and 9.8μg / m L respectively. The precision and repeatability met the chromatographic requirements (RSD = 0.26%, 3.5%). The method was used to detect the content of high molecular weight polymers in 9 batches of flucloxacillin sodium and 7 flucloxacillin sodium capsules, all of which were less than 0.2%. Conclusion The method can be used to separate the main components of flucloxacillin sodium and impurities of polymers and oligomers. It can be used for the determination of flucloxacillin sodium capsules and middle and high molecular weight polymers of flucloxacillin for injection.