高效液相色谱法同时测定盐酸瑞芬太尼原料药六种有关物质

Simultaneous Determination of Six Related Substances in Remifentanil Hydrochloride by HPLC Method

建立高效液相色谱梯度洗脱法同时测定盐酸瑞芬太尼原料药中的六种有关物质。YMC Hydrosphere C18(4.6 mm×0.1 mm 3μm)色谱柱,流动相A为5 g/L碳酸铵水溶液,溶剂为四氢呋喃-水(10︰90),流动相B为乙腈,梯度洗脱,检测波长220 nm,流速1.5 m L/min,柱温35℃,进样量10μL。原料药及六种有关物质峰之间分离度均≥1.5,精密度、稳定性的RSD均<4.2%。结论:该方法准确,简单,能够快速测定出各有关物质的含量,适于盐酸瑞芬太尼原料药的质量控制。

To establish a HPLC method for simultaneous determination of six related substances in remifentanil hydrochloride by HPLC with gradient elution.A YMC Hydrosphere C18 column(4.6 mm×0.1 mm 3μm)was used.The mobile phase A was tetrahydrofuranwater(10︰90,v/v)with 5 g/L ammonium carbonate,and the mobile phase B was acetonitrile.The detection wavelength was 220 nm.The flow rate was 1.5 m L/min.The column temperature was 35℃,and the inject volume was 10μL.The separation degree between the peak of API and the six related substances was≥1.5,and the RSD of the precision and stability was less than 4.2%.Conclusion:This method,is accurate and simple,can determine the content of the related substances quickly,which is suitable for the quality control of remifentanil hydrochloride.