【摘要】 目的:建立合适的计算方法，对盐酸尼卡地平注射液中杂质A5的含量进行准确定量。方法:通过对比盐酸尼卡地平及其杂质A5在不同浓度下的色谱响应值，以及采用定量核磁共振法(q NMR)对杂质A5的结构和纯度进行确证。同时应用面积归一化法、杂质对照品外标法、不加校正因子的主成分自身对照法和加校正因子的主成分自身对照法4种不同的计算方法，对制剂产品中杂质A5含量的计算结果进行分析比较。结果:面积归一化法、不加校正因子的主成分自身对照法与杂质对照品外标法结果比较差异较大，而加校正因子的主成分自身对照法与杂质对照品外标法结果一致。结论:本研究对杂质A5的校正因子进行了确认，证明加校正因子的主成分自身对照法能确保简便、准确地定量盐酸尼卡地平注射液中的杂质A5。更多还原

【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 selfcontrol 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 quantification of impurity A5 in nicardipine hydrochloride injection.更多还原