Liquid Chromatography-mass Spectrometry for Determining Plasma Queti-apine Fumarate in Patients with Bipolar Disorders
Objective:Development and validation of a simple and rapid liquid chromatography-mass spectrometry(LC-MS/MS)method for the determination of quetiapine fumarate in plasma of patients with depression.Methods:The LC-MS/MS method was applied on a Waters ACQUITY UPLC BEH C18 Column(3.0 mm×50 mm,2.5 μm)with 0.1%formate in acetonitrile(A)-0.1%formic acid in water(B)for gradient elution at 0.5 mL·min-1,column temperature at 40℃ injector temperature at 10℃ and injection volume at 2 μL.The accurately aspirated 50 μL of plasma sample was added with 200 μL of sample extract solution containing internal standard,vortex mixed for 90 s and centrifugated at 12 000 r·min-1 for 10 min,then the supernatant was aspirated,filtered through a 0.22 μm syringe filter and injected for quantitative analysis with an internal standard method.Results:The plasma concentrations of quetiapine were linearly deter-mined in the range of 50-1000 ng·mL-1(Y=0.00583X-0.0321,r=0.9996).The RSD values of intraday and inter-day precision of LLOQ,LQC,MQC and HQC were<5.0%,the accuracy was within±15%of the theoretical concentration,the extraction recovery rate was 98.65%-101.18%with RSD<5.0%,and the stability at room temperature,short-term,long-term and freeze-thaw cryopreservation were good(RSD<10%).The mean plasma concentration of 114 patients was(53.68±120.45)ng·mL-1.Conclusion:The LC-MS/MS method is simple to preprocess,has high analytical sensitivity and strong specificity,and can meet the needs of real-time,accurate and rapid detection of plasma quetiapine fumarate in clinical practice.
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