RP-HPLC法测定人血浆中帕利哌酮的浓度

Determination of Paliperidone in Human Plasma by RP-HPLC

目的:建立测定人血浆中帕利哌酮浓度的方法。方法:血样以乙醚处理后采用反相高效液相色谱法进样测定。色谱柱为Agilent Eclipse Plus C18,流动相为甲醇-乙腈-水(1∶5∶14,加入1.88%正丁胺以及1.80%冰醋酸),流速为1.0 ml/min,检测波长为280nm,温度为室温(18~28℃),内标为曲唑酮,湿度<85%。结果:帕利哌酮血药浓度在2.81~180 ng/ml范围内线性关系良好(r=0.999 0);平均方法回收率在99.01%~104.23%之间,日内、日间RSD均<11%。结论:该法操作简便、准确、重复性好,可用于临床监测帕利哌酮的血药浓度。

OBJECTIVE： To establish a method for determining the plasma concentration of paliperidone. METHODS： RP-HPLC method was adopted after samples were treated with ethyl ether using trazodone as internal standard. The determination was performed on Agilent Eclipse Plus C^8 column with mobile phase consisted of methanol-acetonitrile-water （1：5：14 added into 1.88% n-butylamine and 1.80% glacial acetic acid） at flow rate of 1.0 ml/min. The detection wavelength was set at 280 nm and room temperature maintained at 18-28 %. The relative humidity was kept less than 85%. RESULTS： The liner range of palisperi- done were 2.81-180 ng/ml （r=0.999 0） with recovery of 99.01%-104.23%. RSDs of inter-day tests and intra-day were lower than 11%. CONCLUSIONS： The method is simple, accurate and reproducible, and can be used for the determination of plasma concentration of palisperidone in the clinic.