HPLC Method Research of Picoplatin-a New Platinum Anti-cancer Drug and Its Impurities

作     者：LUAN Chunfang CONG Yanwei ZHANG Qi QIU Xueweng BEI Yuxiang PU Shaoping LUAN Chunfang;CONG Yanwei;ZHANG Qi;QIU Xueweng;BEI Yuxiang;PU Shaoping

作者机构：Kunming Guiyan Pharmaceutical Co.Ltd.Kunming 650106China. 

出 版 物：《贵金属》 (Precious Metals)

年 卷 期：2012年第33卷第A01期

页      面：253-257页

学科分类：081704[工学-应用化学] 07[理学] 08[工学] 0817[工学-化学工程与技术] 070302[理学-分析化学] 0703[理学-化学] 

主　　题：platinum-based anti-cancer drug picoplatin HPLC 

摘      要：Purpose: To establish a HPLC testing method of the content of bulk picoplatin and its impurities. Method: the separation was perform on a C18 column(4.6 mm×250 mm, 5 m) with potassium dihydrogen phosphate-aceton-itrile as the mobile phase at a flow rate of 1.0 mL/min. The detecting wavelength was set at 210 nm, and the column temperature was set at 30℃. Result: in the method validation, the linear relationship modulus of picoplatin is 0.9999, the systemic precision is 0.44%, the method precision is 0.74%, the average recovery rate is 99.62%, the LOD and LOQ of picoplatin is 0.2 ng and 1.0 ng. The average resolution of picoplatin and its impurities is more than 2. Conclusion: The established method is good specificity, high sensitivity, and good repeatability which could provide scientific evidence for the quality control of picoplatin and its impurities.