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目的:建立以高效液相色谱法测定聚氰基丙烯酸正丁酯氧氟沙星纳米粒中主药含量的方法。方法:色谱柱为Kromasil C18,流动相为甲醇-四氢呋喃-醋酸盐缓冲液(40∶20∶40),流速为0.5mL.min-1,柱温为25℃,检测波长为293nm。结果:氧氟沙星检测浓度在10.02～60.10μg.mL-1范围内线性关系良好(r=0.9996,n=6),平均加样回收率为99.01%(RSD=0.64%)。结论:本方法操作简便、快速、准确,可用于该制剂的质量控制。
OBJECTIVE: To establish a method for the determination of the main drug in ofloxacin n-butylcyanoacrylate nanoparticles by high performance liquid chromatography. Methods: The chromatographic column was Kromasil C18. The mobile phase was methanol-tetrahydrofuran-acetate buffer (40:20:40), the flow rate was 0.5mL.min-1, the column temperature was 25 ℃ and the detection wavelength was 293nm. RESULTS: Ofloxacin had a good linearity (r = 0.9996, n = 6) in the range of 10.02 ~ 60.10μg.mL-1 with an average recovery of 99.01% (RSD = 0.64%). Conclusion: The method is simple, rapid and accurate and can be used for the quality control of this preparation.