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目的探讨司帕沙星注射液中司帕沙星和有关物质的测定方法。方法高效液相色谱法(HPLC法);采用PhenomenexC18柱(250mm×4.6mm,5μm),以磷酸缓冲液(pH=2.5)-乙腈(65∶35)为流动相,流速为1.0mL/min,检测波长为297nm。结果司帕沙星浓度在2～50μg/mL范围内与峰面积线性关系良好,r=0.9998,平均回收率为99.80%,RSD为0.74%;有关物质的检查准确、专属性强、重现性好,最低检测限为0.5ng(S/N=3)。结论HPLC法灵敏、准确、简便,可用于该产品的质量控制。
Objective To investigate the determination of sparfloxacin and related substances in sparfloxacin injection. Methods The HPLC method was as follows: Phenomenex C18 column (250 mm × 4.6 mm, 5 μm), phosphate buffer (pH = 2.5) -acetonitrile (65:35) was used as the mobile phase at a flow rate of 1.0 mL / Detection wavelength of 297nm. Results Sparfloxacin showed a good linear relationship with the peak area in the range of 2 ~ 50μg / mL with r = 0.9998, the average recovery was 99.80% and the RSD was 0.74%. The related substances were accurate, specific and reproducible Good, the minimum detection limit of 0.5ng (S / N = 3). Conclusion HPLC method is sensitive, accurate and simple and can be used for the quality control of the product.