RP-HPLC法测定乳酸左氧氟沙星含量

Determination of Levofloxacin Lactate in Levofloxacin Lactate and Sodium Chloride Injection by RP-HPLC

目的:建立乳酸左氧氟沙星氯化钠注射液中主药的含量测定方法。方法:采用反相高效液相色谱法,以Lichrospher5-C18为色谱柱;己烷磺酸钠-甲醇(3:1)为流动相;流速为1.0 ml/min;检测波长为293 nm,柱温为40℃,进样量为20 ul。结果:乳酸左氧氟沙星浓度在5.0～50.0μg/ml内线性关系良好(r=0.9995),平均回收率为99.85%,RSD为0.25%。结论:此法准确可靠,重现性好,能有效控制乳酸左氧氟沙星氯化钠注射液的质量。

Objective：To establish a method for quantitative determination of levofloxacin lactate in levofloxacin lactate and sodium chloride injection. Methods：Reversed phase high performance liquid chromatographic separation was carried out on a Lichrospher5-C18 column. The mobile phase was constituted by sodium hexanesulfonate - methanol （3：1）; The flow rate was 1.0 ml/min; The detection was carried out by ultraviolet detector at 293 nm; the column temperature was 40℃ and the sample size was 20 ul. Results：Good linear relation was achieved when the levofloxacin lactate concentration was at the range of 5.0~50.0 μg/ml （r=0.9995）,The average recovery of levofloxaein lactate was 99.85%with RSD= 0.25%. Conclusion：The proposed method is accurate, reliable, and highly selective, and it can act as an effective quality control for levofloxacin lactate and sodium chloride injection.