棓丙酯注射液有关物质检查中没食子酸测定方法的改进

摘要

目的：改进棓丙酯注射液有关物质检查中没食子酸含量的测定方法。方法：采用HPLC法，Agilent ZORBAX SB-C18柱（4.6 mm ×250 mm，5μm），以甲醇-水（用磷酸调节pH值至3.0）为流动相，梯度洗脱，流量1.0 mL· min－1，检测波长为272 nm。结果：改进后的方法能将没食子酸峰与辅料峰完全分离。结论：改进后的没食子酸测定方法更准确，可靠。%Objective:To improve the determination method of Gallic Acid in related substances inspection for Propylgallate Injection.Methods:The HPLC system was performed on an Agilent ZORBAX SB-C18 column (4.6 mm ×250 mm,5μm) with the mobile phase of methanol-water (phosphoric acid adjusted pH to 3.0) by linear gradient elution.The flow rate was 1.0 mL· min-1 and UV detec-tor at 272 nm.Results:The improved method could completely separate the peak of Gallic Acid and adjuvants.Conclusion:The im-proved method for the determination of Gallic Acid is more accurate and reliable.