论文部分内容阅读
目的:建立诺氟沙星滴眼液中诺氟沙星质量的HPLC测定方法。方法:采用SepaxSapphireODSC18色谱柱(250mm×4.6mm,5μm);流动相:0.025mol/L磷酸溶液(用三乙胺调节pH值至3.0±0.1)-乙腈(87:13);流速为0.8mL/min;检测波长:278nm;进样量:20μL。结果:诺氟沙星在0.1～1.0μg/mL范围内呈良好线性关系(r=0.9999,n=5);精密度、重复性和稳定性的相对标准偏差(RSD)分别为0.54%,0.41%和0.53%,均小于1.5%(n=6);加样回收率平均值为100.28%,RSD为0.59%(n=6);每毫升滴眼液中含诺氟沙星2.94mg/mL。结论:该方法简便、快速、准确,可作为诺氟沙星滴眼液含量测定。
Objective: To establish a HPLC method for determination of norfloxacin in norfloxacin eye drops. The mobile phase was 0.025mol / L phosphoric acid (adjusted to pH 3.0 ± 0.1 with triethylamine) -acetonitrile (87:13). The flow rate was 0.8mL / min; detection wavelength: 278nm; injection volume: 20μL. RESULTS: Norfloxacin showed a good linearity (r = 0.9999, n = 5) in the range of 0.1-1.0 μg / mL. The relative standard deviations (RSDs) of precision, repeatability and stability were 0.54% and 0.41 % And 0.53%, respectively, were less than 1.5% (n = 6); the average recovery was 100.28%, RSD was 0.59% (n = 6); Norfloxacin was 2.94mg / mL . Conclusion: The method is simple, rapid and accurate and can be used as the determination of norfloxacin eye drops.