反相高效液相色谱法测定普卢利沙星片中NM394含量及有关物质

RP- HPLC Determination of NM394 Content and Related Substances in Prulifloxacin Tablets

目的 采用反相高效液相色谱（RP-HPLC）法测定普卢利沙星片中NM394含量及有关物质。方法 色谱柱为Phenomenex C18柱（150 mm×4.6 mm,5μm）,流动相A为0.025 mol/L磷酸二氢钠溶液（用三乙胺调pH为6.0）、B为乙腈,梯度洗脱,流速1.0 mL/min,检测波长276 nm。结果 NM394质量浓度在1.2~28.8μg/mL范围内与峰面积呈良好的线性关系,r=0.999 1（n=6）。NM394低、中、高3个质量浓度的平均回收率分别为98.8%,99.7%,99.4%,RSD分别为0.99%,0.61%,0.43%（n=3）。结论 该方法测定普卢利沙星片中NM394含量及有关物质,方法便捷、准确、专属性好。

Objective To adopt the RP-HPLC method to determine the NM394 content and related substances in Prulifloxacin Tablets. Methods The separation was performed on The Phenomenex C18 column （150 mm ×4.6 mm,5μm）. The mobile phase A was 0. 025 mol/L sodium phosphate monobasic dihydrate solution（adjusting to pH =6.0 with triethylamine）;the mobile phase B was acetonitrile. The flow rate was 1.0 mL/min with the gradient elution. The detection wavelength was 276 nm. Results The mass concentration of NM394 in the range of 1.2-28.8 txg/mL exhibited good linear relation with the peak area （r =0. 999 1, n =6）. The average recovery rates in the high, middle and low mass concentrations were 98.8%,99.7% and 99.4% （n = 3） respectively, with RSD of 0.99% ,0.61% and 0.43% （n=3） respectively. Conclusion The method is proved to be quick,simple and accurate and is suitable for the determination of the NM394 content and its related substances in Prulifloxacin Tablets.