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盐酸帕洛诺司琼注射液中异构体含量的NP-HPLC测定
引用本文:潘红娟,王哲峰,时惠麟,俞雄.盐酸帕洛诺司琼注射液中异构体含量的NP-HPLC测定[J].中国医药工业杂志,2009,40(8).
作者姓名:潘红娟  王哲峰  时惠麟  俞雄
作者单位:1. 上海医药工业研究院;创新药物与制药工艺国家重点实验室,上海,200437
2. 上海医药工业研究院
摘    要:建立了正相高效液相色谱(NP-HPLC)法测定盐酸帕洛诺司琼注射液中(R,S)-异构体的含量.样品经氧氧化钠碱化后,再用二氯甲烷提取.用Inertsil SIL-100A色谱柱,二氯甲烷-甲醇-氨水(448:50:2)为流动相,检测波长261 nm.采用加校正因子的主成分自身对照法计算(R,S)-异构体的含量.

关 键 词:盐酸帕洛诺司琼  异构体  正相高效液相色谱  测定

Determination of (R,S)-Isomer in Palonosetron Hydrochloride Injection by NP-HPLC
Authors:PAN Hongjuan  WANG Zhefeng  SHI Huilin  YU Xiong
Abstract:A NP-HPLC method was established for the determination of (R,S)-isomer in palonosetron hydrochloride injection. The samples was treated by NaOH, and then extracted with dichloromethane. An Inertsil SIL-100A column was used, with the mobile phase of dichloromethane-methanol-ammonia solution (448 : 50 : 2), at the detection wavelength of 261 nm. The content of (R,S) - isomer was calculated based on palonosetron as the reference solution calibrated with correction factors.
Keywords:palonosetron hydrochloride  isomer  NP-HPLC  determination
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