摘要
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.
出处
《中国执业药师》
CAS
2016年第5期28-31,共4页
China Licensed Pharmacist