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目的:建立磁性碳微球中5-氟尿嘧啶(5-fluorouracil,5-Fu)含量及包封率的HPLC测定法。方法:色谱柱为Diamon-sil~(TM)ODS-C_(18)柱(200 mm×4.6 mm,5μm),以甲醇-水(10:90)为流动相,流速1.0 ml·min~(-1),检测波长为260 nm,柱温为30℃,采用磁性分离法分离微球和游离药物,测定并计算药物含量和包封率。结果:5-Fu在1.0～300.0μg·ml~(-1)范围内线性关系良好(r=0.999 9),方法回收率为99.52%～100.12%,日内、日间RSD均小于1.0%,制备的微球平均包封率为(66.62±1.18)%,平均载药量为(221.69±3.99)μg·mg~(-1)。结论:本法简便,灵敏,准确,可用于5-Fu磁性碳微球的含量及包封率测定。
OBJECTIVE: To establish an HPLC method for determination of 5-fluorouracil (5-Fu) and encapsulation efficiency in magnetic carbon microspheres. METHODS: Diamon-sil TM ODS-C 18 column (200 mm × 4.6 mm, 5 μm) was used with a mobile phase of methanol-water (10:90) at a flow rate of 1.0 ml · min ~ 1). The detection wavelength was 260 nm and the column temperature was 30 ℃. Microspheres and free drug were separated by magnetic separation. The drug content and entrapment efficiency were measured and calculated. Results: The linearity of 5-Fu in the range of 1.0-300.0 μg · ml -1 was good (r = 0.999 9). The recoveries of the method were 99.52% -100.12%. The intra-day and inter-day RSD were less than 1.0% The average entrapment efficiency of the microspheres was (66.62 ± 1.18)% and the average drug loading was (221.69 ± 3.99) μg · mg ~ (-1). Conclusion: The method is simple, sensitive and accurate and can be used for the determination of the content and entrapment efficiency of 5-Fu magnetic carbon microspheres.