HPLC法测定注射用棓丙酯中的有关物质

Determination of Related Substances in Propylgallate for Injection by HPLC

目的:建立测定注射用棓丙酯中有关物质检查的HPLC方法。方法:采用Agilent HC-C18柱(4.6mm×250mm,5μm);柱温35℃;流动相为甲醇-水(55∶45)(用磷酸调节pH值至3.0);流速0.9mL·min-1;检测波长272nm。结果:棓丙酯主峰与各分解产物峰分离良好,方法的精密度良好(RSD=0.1%,n=6)。结论:该方法准确、简便、快速,适用于注射用棓丙酯的质量控制。

Objective：To establish an HPLC method for determination of related substances in Propylgallate for Injection. Method：The HPLC was performed on Agilent HC-C18 column （4.6 mm×250 mm,5 μm） with methanol-water（55∶45）（adjusted to pH 3.0 with phosphoric acid） as the mobile phase, the detection wavelength was 272 nm. The flow rate was 0.9 mL·min-1. The temperature of the column was 35 ℃. Results： An excellent separation was achieved for Propylgallate and its related substances;The precision of the method was good （RSD=0.1%, n=6）. Conclusion： This method was accurate,simple,quick and effective for testing related substances in Propylgallate for injection.It was also suitable for the quality control of Propylgallate for Injection.