摘要
目的建立测定盐酸帕洛诺司琼有关物质的反相高效液相色谱(RP-HPLC)法。方法色谱柱为Shim-packVP-ODS柱(150mm×4.6mm,5μm),流动相A为0.02mol/L磷酸二氢钾溶液(用磷酸调节pH至2.5)-乙腈(90∶10),流动相B为0.02mol/L磷酸二氢钾溶液(用磷酸调节pH至2.5)-乙腈(60∶40),梯度洗脱,流速1.0mL/min,检测波长210nm。结果在此色谱条件下,盐酸帕洛诺司琼与杂质及降解产物可以有效分离。结论 RP-HPLC法准确、专属性好,适用于盐酸帕洛诺司琼有关物质及降解产物的检测。
Objective To establish a RP-HPLC method for the determination of the related substances in palonosetron hydrochlo- ride. Methods The separation was performed on the Shim-pack VP-ODS column（150 mm × 4. 6 mm,5 μm） . The mobile phase A was composed of 0. 02 mol /L potassium dihydrogen phosphate solution（adjusted pH to 2. 5 with phosphoric acid）-acetonitrile（90 ∶ 10） . The mo- bile phase B was composed of 0. 02 mol /L potassium dihydrogen phosphate solution（adjusted pH to 2. 5 with phosphoric acid）-acetonitrile （60 ∶ 40）. The gradient elution was adopted and the flow rate was 1. 0 mL /min. The detection wavelength was 210 nm. Result The satisfactory separated condition among palonosetron hydrochloride and its related impurities and degradation products was obtained. Conclusion The method is accurate and reproducible,which can be used for the determination of the related substances in palonosetron hydrochloride.
出处
《中国药业》
CAS
2010年第16期25-26,共2页
China Pharmaceuticals
