枸橼酸舒芬太尼有关物质HPLC分析方法的优化

目的:优化枸橼酸舒芬太尼有关物质的HPLC分析方法。方法:以Agilent HC-C18(4.6 mm×250 mm,5μm)色谱柱为固定相,0.13mol.L-1醋酸铵溶液–甲醇–乙腈(31∶45∶24)(用冰醋酸或氨水调节pH值至7.2)为流动相;检测波长为228 nm;流量1.5 mL.min-1。结果:枸橼酸舒芬太尼峰与各杂质峰能得到较好分离,舒芬太尼及其中间体脱苄物、醚化物、丙酰化物的检测限分别为0.36,0.32,0.64,2.80 ng。结论:该方法灵敏度高,专属性强,可用于枸橼酸舒芬太尼的有关物质的检测。

Optimization of HPLC Method for Determination of Related Substances of Sufentanil Citrate

Objective： To Optimize an HPLC method for the determination of related substances of su~entanil sitrate. Methods： The HPLC condition were consisted of an Agilent HC-Cts （4.6 mm × 250 mm,5 μm） column with mobile phase of 0. 13 mol· L- 1 ammonium acetate solution- methanol -aeetonitrile （ 31 ： 45 ： 24 ） adjusted pH value to 7.2 with acetic acid or ammonia. The flow rate was 1.5ml · min-1and the detection wavelength was at 228nm. Results： Snfentanil citrate peak was completely separa- ted with peaks of impurities. The detection limit of sufentanil and its intermediate of debenzylation , etherification, propionylation were 0.36, 0.32, 0.64, 2.80 ng. Conclusion：The method is sensitive and accurate, and is suitable for the quality control of sufentanil sitrate.