Comparative study on different quantitative calculation methods for impurity A5 in nicardipine hydrochloride injection
JIN Ling-jiao
XIE Ya-ting
WANG Lei
ZHAO Long-shan
Abstract：Objective:To establish a suitable calculation method to accurately quantify the content of impurity A5 in nicardipine hydrochloride injection.Methods:The chromatographic responses values of nicardipine hydrochloride and its impurity A5 at different concentrations were compared,and quantitative nuclear magnetic resonance(qNMR)was used to confirm the structure and purity of impurity A5.The calculation results of the impurity A5 content in the drug product by using different methods such as area normalization method,external standard method,principal component self-control method without correction factor,and principal component self-control method with correction factor were analyzed and compared.Results:The results of area normalization method,principal component self-control method without correction factor and external standard method were quite different,but the results of principal component self-control method with correction factor were consistent with those of external standard method,which shows that accurate quantification of impurity A5 in nicardipine hydrochloride injection can be performed using the external standard method or the self-control method with a correction factor.Conclusion:This study confirms the correction factor for impurity A5 and demonstrates that the principal component self-control method,when employed with a correction factor,guarantees rapid,straightforward,and precise quanti-fication of impurity A5 in nicardipine hydrochloride injection.
Keywords：nicardipine hydrochlorideimpurity A5correction factorqNMRquantitative methods
Publication Date：2026-01-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 205-212 )