摘要
目的:建立高效液相串联质谱方法测定人血浆中伊潘立酮的药物浓度。方法:方法色谱柱为Kromasil 60-5CN(100mm×2.1mm,5μm),流动相:乙腈与5mmol·L-1醋酸铵缓冲液(含0.1%甲酸)体积比为35∶65,流速为0.3mL·min-1,吡格列酮为内标,采用电喷雾离子源,以多反应监测(MRM)方式进行正离子检测。用于定量分析的离子分别为m/z 427.2→m/z261.2(伊潘立酮),m/z357.2→m/z133.8(吡格列酮,内标)结果:伊潘立酮的血浆浓度在20~20 000pg·mL-1范围内线性良好,定量下限为20pg·mL-1,日内精密度<3%,日间精密度<9%,回收率为96.9%~101%。结论:该法操作简单,灵敏,准确,重现性好,适用于伊潘立酮人体药动学研究及生物等效性研究。
OBJECTIVE To establish a LC-MS/MS method for the determination of iloperidone in human plasma. METH- ODS The separation was performed on Kromasil 60-5CN column (100 mm× 2. 1mm,5 μm). Using acetonitrile 5 mmol. L^- 1 ammonium acetate (35:65) containing 0. 1 % formic acid as the mobile phase at a flow rate of 0. 3 mL·min^-1. Pioglitazone was used as internal standard. Etectrospray ionization (ESI) source was applied and operated in the positive ion mode. Multiple re- action monitoring (MRM) mode with the transitions of m/z 427.2→ m/z 261.2 and ra/z 357. 2 →m/z 133.8 was used to quantify iloperidone and IS, respectively. RESULTS In human plasma, the standard curve was linear from 20- 20 000 pg. mL^-1. The lower limit of quantification of faropenem was 20 pg.mL^- 1. The RSD of within day was less than 3%, the RSD of between day was less than 9%, and the method recovery rate was 96. 9~101%. CONCLUSION The method is simple, sen- sitive,accurate and reproducible It is applicable for pharmacokinetic study of iloperidone for the clinical pharmacokinetics and bioequivaence studies.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2012年第24期1971-1974,共4页
Chinese Journal of Hospital Pharmacy