Determination of Risperidone and 9-hydroxyrisperidone in Human Plasma by LC-MS/MS / 中国药房

ABSTRACT

OBJECTIVE:To establish the method for simultaneous determination of risperidone (RIS) and 9-hydroxyrisperi-done (9-OH-RIS) in human plasma. METHODS:After liquid-liquid extraction of plasma sample,using AF2672 as internal stan-dard(IS),LC-MS/MS was adopted. The determination was performed on XtimateTM C18 column with mobile phase consisted of ace-tonitrile-10 mmol/L ammonium acetate solution(containing 0.1％ formic acid)(3763,V/V,pH=3.2)at the flow rate of 0.25 mL/min. The column temperature was 40 ℃,and the sample size was 6 μL. The ESI was equipped and quantitative analysis was operated in positive ion and MRM mode. The mass transition ion-pairs were followed as m/z 411.26→191.02 for RIS,m/z 427.21→206.91 for 9-OH-RIS and m/z 418.00→175.95 for IS. RESULTS:The linear range of RIS was 0.2-50.0 ng/mL(r=0.9997)and 9-OH-RIS was 1.0-200.0 ng/mL (r=0.9987). RSDs of inter-day and intra-day were all lower than 15％,and the method recoveries were 92.42％-104.81％ and 94.51％-100.57％;matrix effects were 98.33％-107.09％ and 91.05％-105.80％;extraction recoveries were 78.11％-92.62％ and 76.32％-85.09％,respectively. The plasma concentrations of RIS and 9-OH-RIS in 78 schizophrenic patients were(13.58±8.31)and(25.62±15.52)ng/mL. CONCLUSIONS:The developed method is simple,sensitive and specific,which is suitable for routine drug monitoring and acute toxic analysis in patients receiving risperidone.