HPLC法同时测定盐酸帕洛诺司琼注射液中3种杂质的含量

HPLC Determination of Three Impurities in Palonosetron Hydrochloride Injection

目的:建立HPLC法测定盐酸帕洛诺司琼注射液中还原杂质、差向异构体、氮氧杂质等3种杂质含量的方法。方法:采用Inertsil ODS-3 C_(18)色谱柱(4.6 mm×250 mm,5μm),流动相为高氯酸钠缓冲液-乙腈(72∶28),检测波长为210 nm,柱温为30℃,流量为1.0 m L·min^(-1)。结果:在选定的色谱条件下,还原杂质、差向异构体、氮氧杂质可准确测定,方法学考察符合分析检测要求。结论:建立的方法灵敏度高,测定结果准确,可用于盐酸帕洛诺司琼注射液中3种杂质的含量测定。

Objective：To develop an HPLC method for the determination of Desoxy-Palonosetron Dihydrochloride,Epimer-Palonosetron Hydrochloride and N-Oxide-Palonosetron in Palonosetron Hydrochloride Injection. Method： The assay was performed on a Inertsil ODS-3 C18 column（4. 6 mm×250 mm,5 μm） with sodium perchlorate buffer solution-acetonitrile （72： 28）as mobile phase at the flow rate of 1.0 mL . min-1 ;The column temperature was set at 30 ℃ and detected with UV 210 nm. Results：The assay of Desoxy-Palonosetron Dihydrochloride, Epimer-Palonosetron Hydrochloride and N-Oxide-Palonosetron was determined accurately under the selected HPLC conditions, and the methodological studies conformed to the requirements for analysis. Conclusion.The method can be used for the assay of three impurities in Palonosetron Hydrochloride Injection with high sensitivity, accurate and reliable results.