摘要
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 the high molecular polymer detection method for Flucloxacillin sodium capsule and Flucloxacillin sodium for injection. Methods Gel filtration chromatography was performed via Sephadex G10 gel column. The mobile phase was consisted of A, 0.1 mol/Lphosphate buffer （pH7.0） and B, water. The flow rate was 1.2mL/min, the detection wavelength was 254nm and the injection volume was 100μL. The concentration of polymers was quantified by the external standard method of reference oneself （ESMOROS）. Results The established method was validated. The linearity of this method was 10~245μg/mL （0.9995）; detection limit and lowest quantitation limit were 5.8μg/mL, 9.8μg/mL. Repeatability and accuracy （RSD=0.26%, 3.5%） of this method meet the requirement of chromatography. The new method was applied to detect 9 batches of Flucloxacillin sodium for injection and 7 batches of Flucloxacillin sodium capsules and the concentrations of the polymers were less than 0.2%. Conclusion This method could be used to properly separate polymers and oligomers from the principal component and could be applied to determine high molecular polymers in Flucloxacillin sodium capsule and Flucloxacillin sodium for injection.
出处
《国外医药（抗生素分册）》
CAS
2017年第1期44-48,共5页
World Notes on Antibiotics
关键词
氟氯西林钠
聚合物
凝胶色谱法
flucloxacillin sodium
polymer
gel filtration chromatography
