Yuan Lijuan, Liu Weiguo, Zhang Shengshuo, Huang Lihong, Cheng Jiangmin, He Lanxiang, Zhao Hangyu, Yu Yonghua
Department of Pharmacy, Linping District First People'sHospital of Hangzhou, Hangzhou, Zhejiang Province 311100, China.
Department of Oncology, The People's Hospital of Jiangshan, Quzhou, Zhejiang 324100, PR China.
ACS Omega. 2025 Aug 19;10(34):39212-39224. doi: 10.1021/acsomega.5c06016. eCollection 2025 Sep 2.
In this study, a liquid chromatography method was developed and validated for the accurate determination of carvedilol content while minimizing interference from impurity C and -formyl carvedilol and allowing precise impurity analysis. The reliability of the method was verified through key parameters such as linearity, precision, accuracy, and stability, ensuring robust performance in the detection and quantification of carvedilol and related impurities. And, the method was tested under varying conditions, including changes in the flow rate, initial column temperature, and mobile phase pH. The results showed that the method demonstrated excellent linearity, with values consistently above 0.999 for all analytes. Precision tests yielded RSD% values below 2.0%, confirming the method's repeatability. Accuracy assessments revealed recovery rates ranging from 96.5% to 101%, while stability studies indicated minimal variation in peak areas and impurity content over extended time periods. These results confirm the method's reliability for accurate quantification and impurity analysis in pharmaceutical samples.
在本研究中，开发并验证了一种液相色谱法，用于准确测定卡维地洛含量，同时将杂质C和甲酰基卡维地洛的干扰降至最低，并实现精确的杂质分析。通过线性、精密度、准确度和稳定性等关键参数验证了该方法的可靠性，确保在卡维地洛及相关杂质的检测和定量中具有稳健的性能。并且，该方法在不同条件下进行了测试，包括流速、初始柱温及流动相pH的变化。结果表明，该方法具有出色的线性，所有分析物的 值均始终高于0.999。精密度测试得到的RSD%值低于2.0%，证实了该方法的可重复性。准确度评估显示回收率在96.5%至101%之间，而稳定性研究表明在较长时间段内峰面积和杂质含量的变化极小。这些结果证实了该方法在药物样品中进行准确定量和杂质分析的可靠性。
