Development and Validation of a Stability-Indicating HPLC Method for the Determination of the Impurities in Cabazitaxel

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• 作者：Chengyan Li ; Gongjian Lan ; Jinyuan Jiang ; Mingjie Sun ; Taijun Hang
• 关键词：HPLC ; Cabazitaxel ; Impurity ; Method validation
• 刊名：Chromatographia
• 出版年：2015
• 出版时间：June 2015
• 年：2015
• 卷：78
• 期：11-12
• 页码：825-831
• 全文大小：503 KB
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• 作者单位：Chengyan Li (1) (2)
  Gongjian Lan (2)
  Jinyuan Jiang (2)
  Mingjie Sun (2)
  Taijun Hang (1)
  
  1. China Pharmaceutical University, Nanjing, Jiangsu, 210009, People’s Republic of China
  2. Xiangbei Welman Pharmaceutical Co., Ltd, Changsha, Hunan, 410331, People’s Republic of China
  
• 刊物类别：Chemistry and Materials Science
• 刊物主题：Chemistry
  Analytical Chemistry
  Organic Chemistry
  Pharmacy
  Biochemistry
  Plant Sciences
  Measurement Science and Instrumentation
  
• 出版者：Vieweg Verlag
• ISSN：1612-1112

文摘

A novel stability-indicating high-performance liquid chromatographic (HPLC) method has been developed and validated for the analysis of the impurities A–G in cabazitaxel. Chromatographic separation was achieved on a Welch Xtimate?C18 (250?×?4.6?mm; 5?μm) column, using the mixture of 0.02?mol?L? sodium dihydrogen phosphate buffer pH 3.0 (pH value was adjusted with phosphoric acid) and acetonitrile as mobile phase by gradient elution with a flow rate of 1.0?mL?min?, and UV detection was performed at 230?nm. The column temperature was maintained at 40?°C by column oven. The method was validated according to the International Conference on Harmonization (ICH) guidelines. Linearity (r?>?0.9990) was observed over the concentration ranges of 25.0-500.0, 31.5-518.0, 74.9-796.8, 65.6-573.2, 59.4-425.6, 22.2-332.0, 1.3-570.8, 30.8-476.0?ng?mL? of cabazitaxel and its impurities A–G, respectively. The RSD value of the recovery for each impurity was <5.0?% (n?=?9). The method was found simple and rapid with good specificity and robustness, which can be suitable for the determination of the impurities in cabazitaxel.