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目的:建立RP-HPLC法测定氟哌利多注射液的有关物质及含量的检测方法。方法:采用Diamonsil C18(150mm×4.6mm,5μm)色谱柱,流动相为乙腈-0.1%三乙胺,醋酸调pH至5.9,梯度洗脱流速:1.0mL·min-1,检测波长:275nm,柱温:35℃。结果:氟哌利多的线性范围为50～150μg·mL-1,相关系数为:0.9996。回收率(n=9)为100.8%。结论:该方法简便准确,重复性好,可为控制氟哌利多注射液的含量和有关物质的质量标准提供参考。
Objective: To establish a method for the determination of related substances and contents of droperidol injection by RP-HPLC. Methods: Diamonsil C18 (150mm × 4.6mm, 5μm) was used as the mobile phase. The mobile phase was acetonitrile-0.1% triethylamine. The pH was adjusted to 5.9 with acetic acid. The gradient elution was 1.0mL · min- Column temperature: 35 ° C. Results: The linear range of droperidol was 50 ~ 150μg · mL-1 with a correlation coefficient of 0.9996. The recovery (n = 9) was 100.8%. Conclusion: The method is simple, accurate and reproducible. It can provide a reference for controlling the content of droperidol injection and the quality standards of related substances.