棓丙酯注射液有关物质检查中没食子酸测定方法的改进  

Improvement of Gallic Acid Determination in Related Substances Inspection for Propylgallate Injection

作　　者：杨本霞[1] 袁利杰[1] 李婷婷[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国药品标准》2015年第5期362-364,共3页Drug Standards of China

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-C_(18)柱(4.6 mm×250 mm,5μm),以甲醇-水(用磷酸调节p H值至3.0)为流动相,梯度洗脱,流量1.0 m L·min^(-1),检测波长为272nm。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,5 μm） 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 detector at 272 nm. Results： The improved method could completely separate the peak of Gallic Acid and adjuvants. Conclusion：The improved method for the determination of Gallic Acid is more accurate and reliable.

关 键 词：棓丙酯注射液 没食子酸 有关物质 

分 类 号：R921.2[医药卫生—药学]