Bottle-in technology combined with rapid LC-MS to improve the determination efficiency of risperidone plasma concentration
Objective To evaluate the methodological characteristics of Bottle-in technology combined with rapid liquid chromatography-mass spectrometry(LC-MS)and to validate its contribution to the automation and standardization of therapeutic drug monitoring.Methods Risperidone and its main metabolite,9-hydroxyrisperidone,were selected as the research subjects.Corresponding LC-MS detection methods were established and validated for two blood sample pretreatment techniques(Bottle-in technology and the routine processing(RP)technology currently in use in the laboratory).The experimental design followed CLSI EP9-A3 guidelines.Both methods were used to determine the concentrations of risperidone and 9-hydroxyrisperidone in the blood samples of 60 patients taking risperidone,and the report time of the samples was recorded.Spearman correlation analysis,Passing-Bablok regression analysis,Bland-Altman agreement test,and medical decision level(MDL)expected bias analysis were used to evaluate the correlation and differences between the detection results of both methods.Results The LC-MS methods with both pretreatment techniques met the methodological validation standards for the determination of risperidone and 9-hydroxyrisperidone blood drug concentrations.Results in both groups of showed no outliers in the samples of 60 patients,indicating a strong correlation(P＜0.01).The Passing-Bablok regression model showed a good linear relationship.The Bland-Altman agreement test indicated a high degree of consistency between the two methods.MDL expected bias analysis further confirmed that the results of the two detection methods showed no significant bias,with the expected bias values(Bc)all within the acceptable limits.Bottle-in technology and RP technology might save 66.67％of pre-processing time.Combined with rapid LC-MS technology,the detection time of 12 patient samples in the Bottle-in group was shortened by 12.50％compared to the RP group in the entire process.Conclusion The Bottle-in technology,with its efficient sample pretreatment approach can improve the automation and standardization of therapeutic drug monitoring,which serves as an effective alternative to the RP technique,marking a significant advancement in modern clinical pharmacological monitoring.
Bottle-in technologysample pretreatment techniquerapid LC-MStherapeutic drug monitoring technology
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