HPLC测定盐酸帕洛诺司琼原料药中光学异构体

Determination of Isomers and Enantiomer in Palonosetron Hydrochloride by HPLC

目的:建立高效液相色谱法测定盐酸帕洛诺司琼中光学异构体含量的方法。方法:对于非对映异构体,采用C_(18)色谱柱,以乙腈-25 mmol/L磷酸二氢钠溶液(含0.1%三乙胺,用磷酸调p H值至4.0)(25∶75)为流动相;对于对映异构体,采用Chiralcel,OD-RH色谱柱,以100 mmol六氟磷酸钾水溶液-乙腈(70∶30)为流动相;非对映异构体和对映异构体检测波长分别为217 nm和240 nm。结果:盐酸帕洛诺司琼4个异构体线性关系良好,定量限和检测限、方法回收率满足要求。结论:本法灵敏、可靠,可用于盐酸帕洛诺司琼中光学异构体的质量控制。

Objective ：To develop a HPLC method for determination of isomers and enantiomer in palonosetron hydrochloride. Methods ：Isomers were determined by a C_（18） column with the mobile phase of 25 mmol/L sodium dihydrogen phosphate buffer（containing 0.1% triethylamine, of which p H value was adjusted to 4.0 by phosphoric acid）-acetonitrile（75 ∶25）. However, enantiomers were determined by a Chiralcel, OD-RH column with the mobile phase of 100 mmol potassium hexafluorophosphate solution-acetonitrile（70 ∶30）. The wavelengths for detection of isomers and enantiomers were 217 and 240 nm respectively. Results ：The calibration curve of isomers and enantiomers of palonosetron hydrochloride showed good linearity, while the LOQ, LOD and accuracy met the relevant requirements. Conclusion ：The developed methods was sensitive and reliable, which might be used for the quality control of isomers and enantiomer in palonosetron hydrochloride.