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Correlation Of High Performance Liquid Chromatography-Tandem Mass Spectrometry( HPLC-MS / MS) And Microparticle Enzyme Immunoassay(MEIA) In Measuring Plasma Concentration Of Digoxin

Posted on:2016-01-24Degree:MasterType:Thesis
Country:ChinaCandidate:C H GuoFull Text:PDF
GTID:2284330461968935Subject:Pharmacology
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Objective: To establish a High performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS) method to detect plasma concentration of digoxin. To compare difference and relevance, digoxin clinical samples were determined by both HPLC-MS / MS method and microparticle enzyme immunoassay(MEIA)method.Methods: Determination of plasma digoxin plasma concentration was by the HPLC-MS/MS method, including standard curve, LOQ, LOD, precision, accuracy, matrix effects and extraction recovery and stability of the method validation experiments. Collected in our hospital in 2013 to accept digoxin steady-state concentrations of plasma samples of 50 patients, respectively, were determined by MEIA method and HPLC-MS/MS method. The two sets of data were paired with t test.Results: The results show that the method has high sensitivity and specificity, consistent method validation, the plasma concentration of digoxin can be used in the determination. MEIA assay with HPLC-MS/MS method digoxin QC sample showed no significant difference between the two methods. Compared the results of HPLC-MS/MS and MEIA method, the HPLC-MS/MS result was closer to the true result. For the 50 cases of digoxin plasma samples, MEIA method and HPLC-MS/MS method for the determination of the mean results were 2.98ng/m L and 0.06ng/m L. MEIA method of measurement results was significantly higher than HPLC-MS/MS method results with statistically significant differences(P<0.01). Description MEIA method interference has larger error in the determination of digoxin plasma concentration.Conclusion: Digoxin QC sample results showed no statistical difference between the two methods. Two methods for determination of digoxin concentrations were statistically significant difference between the results. Due to the interference of immunoreactive substances, MEIA method in the determination of digoxin concentration subject to larger errors. HPLC-MS/MS method has no cross-reaction interference by metabolites, endogenous substance(DLIS). The measurement result of HPLC-MS/MS method was closer to the sample true result than MEIA method. This HPLC-MS/MS method is suitable for the determination of digoxin in clinic, worthy of promotion.
Keywords/Search Tags:Liquid chromatography-tandem mass spectrometry, micr oparticle enzyme immunoassay, digoxin, Plasma concentration, correlation
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