HPLC法测定注射用棓丙酯中的有关物质

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。

Determination of Related Substances in Propylgallate for Injection by HPLC

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.