HPLC法测定注射剂中抗氧剂168及其降解物含量  

Determination of Antioxidant 168 and Its Degradation Product in Injections by HPLC

作　　者：李沛 苏艳婧 李超 LI Pei;SU Yanjing;LI Chao(Nanjing Chia-Tai Tianqing Pharmaceutical Company,Nanjing 210038,China)

机构地区：[1]南京正大天晴制药有限公司,江苏南京210038

出　　处：《山东化工》2024年第19期180-185,189,共7页Shandong Chemical Industry

摘　　要：目的:建立注射剂中抗氧剂168及其降解物(DBP)含量的测定方法。方法:采用Agilent Eclipse Plus C18(4.6 mm×150 mm,5μm)色谱柱;流动相为甲醇-水梯度洗脱;紫外检测器,检测波长为275 nm;流速为1.2 mL/min;进样量为20μL。结果:抗氧剂168和DBP在约0~10μg/mL范围内线性关系良好,相关系数均大于0.999。抗氧剂168回收率范围在99%~105%,RSD为2.1%;DBP回收率范围在97%~101%,RSD为1.1%。结论:该方法具有良好的专属性、检测灵敏度、精密度、线性和准确度,可用于注射剂中抗氧剂及其降解物的质量控制。Objective:To establish a method for determination of antioxidant 168 and its degradation product(DBP)in injections.Methods:Agilent Eclipse Plus C 18(4.6 mm×150 mm,5μm)was adopted with the mobile phase of methanol-water(gradient elution)at a flow rate of 1.2 mL/min.The detection wavelength was 275 nm and the injection volume was 20μL.Results:The method had good linear relationship within the range about 0~10μg/mL for antioxidant 168 and DBP,with the correlation coefficients all greater than 0.999.Antioxidant 168 recovery was between 99%and 105%,with RSD of 2.1%and DBP recovery was between 97%and 101%,with RSD of 1.1%.Conclusion:The method has good specificity,sensitivity,precision,linearity,accuracy.It can be used for quality control of antioxidant 168 and DBP in injections.

关 键 词：抗氧剂168 DBP HPLC 

分 类 号：O657.7[理学—分析化学] R917[理学—化学]