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目的:建立高效液相色谱法测定盐酸环丙沙星胃漂浮型缓释片含量的方法。方法:以Kromasil C_(18)(250 mm×4.6mm,5μm)柱为色谱柱,流动相为乙腈-0.05 mol·L~(-1)柠檬酸水溶液(20:80),检测波长为277 nm,流速为1 ml·min~(-1),柱温为30℃,进样量10μl。结果:盐酸环丙沙星在4.48~26.89μg·ml~(-1)(r=0.999 2)浓度范围内有良好的线性关系,平均回收率为99.98%,RSD=1.02%。结论:本方法简便、准确、专属性强,可用于该制剂的质量控制。
Objective: To establish a method for the determination of ciprofloxacin hydrochloride sustained-release tablets by HPLC. Methods: Kromasil C 18 column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of acetonitrile-0.05 mol·L -1 citric acid solution (20:80) and the detection wavelength was 277 nm , The flow rate was 1 ml · min ~ (-1), the column temperature was 30 ℃, and the injection volume was 10μl. Results: Ciprofloxacin had a good linearity in the range of 4.48 ~ 26.89 μg · ml -1 (r = 0.999 2) with an average recovery of 99.98% and RSD of 1.02%. Conclusion: The method is simple, accurate and specific and can be used for the quality control of the preparation.