摘要
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 an RP-HPLC method for determination the contents of droperidol injection and its related substances.Methods：The contents of injectio droperidoli was measured by RP-HPLC with a column of Diamonsil C18（150 mm×4.6 mm,5 μm）,acetonitrile-0.1% triethylamine（adjusted to pH 5.9 with acetic acid）,the mobile phase with linear gradient,the flow rate was 1.0 mL·min^-1,the detection wavelengths was 275 nm,the column temperature was 35 ℃.Results：The calibration curves showed good linearity in the range of 50^-150 μg·mL^-1,correlation coefficients was 0.9996.The average recoveries （n=9） was 100.8%.Conclusion：An accurate and reproducible method can be used for the quality control of injectio droperidoli.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第4期669-671,共3页
Chinese Journal of Pharmaceutical Analysis
