Determination of related substances in peramivir injection by HPLC method
10.19778/j.chp.2025.02.014
- VernacularTitle:HPLC法测定帕拉米韦注射液中的有关物质
- Author:
Yang CAO
1
;
Chuang LIU
1
;
Lina WANG
1
;
Jingjing SUN
1
Author Information
1. 吉林省药品检验研究院,长春 130033
- Publication Type:Journal Article
- Keywords:
HPLC;
peramivir;
related substances;
correction factor;
quality control
- From:
Drug Standards of China
2025;26(2):213-220
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a high-performance liquid chromatography method for the determination of related substances in panamivir injection.Methods:The Waters Xbridge Peptide BEH C18(250 mm×4.6 mm,3.5 μm).Phosphate buffer-acetonitrile was used as mobile phase,gradient elution,flow rate 0.8 mL·min-1,column temperature 35℃,detection wavelength 210 nm.Results:Peramivir could be effectively separated from all known impurities,with a limit of quantification of 5.29-18.02 ng and a limit of detection of 1.59-5.41 ng,with a good linear relationship(r＞0.999 0)in the range of 200%of the limit of quantification to the limit concen-tration,and the average recovery rate of each impurity was 99.6%-106.8%(n=12).The results of three batches of peramivir injection samples showed that the known impurities and other largest single impurities were less than 0.2%,and the total impurities were less than 1.0%.Conclusion:Verified by analytical methodology,the method is convenient,fast,specific,sensitive,and accurate,and can be used for the determination of peramivir injection-related substances.
