普卢利沙星片含量和有关物质检测方法的研究

摘要

目的：完善普卢利沙星片含量及有关物质的检测方法。方法：采用C18色谱柱，以0.1％磷酸溶液（三乙胺调节pH值至4.0）为流动相A，乙腈为流动相B，含量测定采用等度洗脱流动相A-流动相B（55∶45），有关物质采用梯度洗脱，检测波长为278nm。结果：主峰和杂质峰能得到良好的分离，普卢利沙星在12.9～413.8μg·mL-1浓度范围内，杂质NM394在1.23～39.36μg·mL-1浓度范围内呈良好线性关系；含量测定平均回收率为101.3％，RSD为1.46％（n＝9）。结论：该法专属性强，灵敏、准确，可作为普卢利沙星片的质量控制方法。%Objective:To perfect the HPLC method for determination and related substances of prulifloxacin tablets.Methods: The separation was performed on a C18 column with a mixture of 0.1%phosphoric acid solution ( three triethylamine adjusted to pH4) as mobile phase A, acetonitrile as mobile phase B, isocratic elution A:B (55∶45) for determination and gradient elution for related sub-stances.The UV detection wavelength was 278 nm.Results:Prulifloxacin was well separated from other impurities.The calibration curve of prulifloxacin was linear in the range of 12.9-413.8 μg· mL-1.The calibration curve of impurity NM 394 was linear in the range of 1.23-39.36 μg · mL-1.The average recoveries ( n=9 ) was 101.3% ( RSD =1.46%).Conclusion: The method is proved to be specific , sensitive and accurate and could be used to control the quality of prulifloxacin tablets .