Development of a Two-Dimensional Liquid Chromatography Online Deproteinization Method for Determining Paclitaxel-Related Substances in a Paclitaxel Injection (Albumin-Bound)
Jing Yao,
Xuejia Zhao,
Yifei Jiang,
Limin Zuo,
Xiaodan Qiu,
Xiaofang Lian,
Huiyi Liu,
Qingying Jia,
Huimin Sun,
Guangzhi Shan
Affiliations
Jing Yao
National Institutes for Food and Drug Control, No. 2, Tian Tan Xi Li, Beijing 100050, China
Xuejia Zhao
Institute of Medicinal Biotechnology, Peking Union Medical College & Chinese Academy of Medical Sciences, No. 1, Tian Tan Xi Li, Beijing 100050, China
Yifei Jiang
Institute of Medicinal Biotechnology, Peking Union Medical College & Chinese Academy of Medical Sciences, No. 1, Tian Tan Xi Li, Beijing 100050, China
Limin Zuo
Institute of Medicinal Biotechnology, Peking Union Medical College & Chinese Academy of Medical Sciences, No. 1, Tian Tan Xi Li, Beijing 100050, China
Xiaodan Qiu
Institute of Medicinal Biotechnology, Peking Union Medical College & Chinese Academy of Medical Sciences, No. 1, Tian Tan Xi Li, Beijing 100050, China
Xiaofang Lian
Institute of Medicinal Biotechnology, Peking Union Medical College & Chinese Academy of Medical Sciences, No. 1, Tian Tan Xi Li, Beijing 100050, China
Huiyi Liu
Institute of Medicinal Biotechnology, Peking Union Medical College & Chinese Academy of Medical Sciences, No. 1, Tian Tan Xi Li, Beijing 100050, China
Qingying Jia
Institute of Medicinal Biotechnology, Peking Union Medical College & Chinese Academy of Medical Sciences, No. 1, Tian Tan Xi Li, Beijing 100050, China
Huimin Sun
National Institutes for Food and Drug Control, No. 2, Tian Tan Xi Li, Beijing 100050, China
Guangzhi Shan
Institute of Medicinal Biotechnology, Peking Union Medical College & Chinese Academy of Medical Sciences, No. 1, Tian Tan Xi Li, Beijing 100050, China
To determine the paclitaxel-related substances in a paclitaxel injection (albumin-bound), it is necessary to remove human blood albumin from the sample via solid-phase extraction and subsequently perform high-performance liquid chromatography analysis. The pre-processing operation is complicated, the duration of analysis is long, and much human power and material resources are needed in the sample testing process. Thus, the purpose of this study was to develop a quick two-dimensional liquid chromatography method that requires less consumables and possesses high sensitivity. Samples were directly injected into one-dimensional solid-phase extraction columns to remove human blood albumin. Paclitaxel and its related substances in the solid-phase extraction columns were then eluted into two-dimensional analytical columns through valve switching technology. The sample pretreatment step can be omitted in this method, which allows for the analysis of paclitaxel and its related substances to be completed more quickly, within only 15 min, under the developed two-dimensional elution conditions. The established method had good linearity (R2 = 0.9994), limit of detection (0.25 μg·mL−1), limit of quantification (0.5 μg·mL−1), precision (RSD = 0.5%), and accuracy (102.53–107.97%).
